Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA product code KWS · 176 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3660
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-12-31 – 2026-07-22

KWS 2026-07-22

Tornier Perform Advanced Glenoid

Applicant Tornier, Inc.

K number K260721

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KWS 2026-04-06

AETOS Shoulder System - CONCELOC Glenoids

Applicant Smith & Nephew, Inc.

K number K254084

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KWS 2025-11-06

Catalyst F1x Shoulder System

Applicant Catalyst Orthoscience, Inc.

K number K252418

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KWS 2025-10-29

AETOS Shoulder System Meta Humeral Prosthesis Size 0

Applicant Smith & Nephew, Inc.

K number K252416

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KWS 2025-01-30

MyShoulder Planner (5.3SSWPL)

Applicant Medacta International S.A.

K number K241292

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KWS 2024-12-06

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

Applicant Stryker Corporation (Tornier, Inc.)

K number K241878

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KWS 2024-09-10

Tornier Humeral Reconstruction System (Tornier HRS)

Applicant Stryker Corporation (Tornier, Inc.)

K number K241609

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KWS 2023-09-26

Arthrex Univers Apex OptiFit Humeral Stem

Applicant Arthrex, Inc.

K number K230513

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KWS 2023-06-23

AltiVate® Anatomic Shoulder AG e+™ with Markers

Applicant Encore Medical L.P.

K number K222592

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KWS 2023-06-07

AETOS Shoulder System

Applicant Smith & Nephew, Inc.

K number K230572

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KWS 2023-01-03

AETOS Shoulder System

Applicant Smith & Nephew, Inc.

K number K220847

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KWS 2022-11-10

Catalyst EA Convertible Stemmed Shoulder

Applicant Catalyst Orthoscience, Inc.

K number K222317

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KWS 2022-07-07

AltiVate® Anatomic Shoulder AG e+™ with Markers

Applicant Encore Medical L.P.

K number K213387

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KWS 2022-05-13

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid

Applicant Limacorporate

K number K213785

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KWS 2022-03-11

TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)

Applicant Smith & Nephew, Inc.

K number K213827

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KWS 2022-03-04

Exactech® Equinoxe® Laser Cage Glenoid

Applicant Exactech, Inc.

K number K212356

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KWS 2021-12-10

Comprehensive Humeral Fracture Positioning Sleeves

Applicant Biomet, Inc.

K number K212435

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KWS 2021-09-03

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K number K210861

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KWS 2021-06-07

Augmented VaultLock Glenoid

Applicant Arthrex, Inc.

K number K210050

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KWS 2021-04-15

BLUEPRINT™ Patient Specific Instrumentation

Applicant Tornier S.A.S.

K number K203315

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KWS 2021-04-02

Global Shoulder and Delta CTA systems

Applicant Depuy Lnc.

K number K203230

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KWS 2020-12-23

AltiVate® Anatomic Pegged Glenoid with Markers

Applicant Encore Medical L.P.

K number K203026

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KWS 2020-12-16

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K number K202289

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KWS 2020-02-24

Alliance Augmented Glenoid

Applicant Zimmer, Inc.

K number K193180

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KWS 2019-11-15

SmartSPACE Shoulder System

Applicant Techmah Medical, LLC

K number K191247

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KWS 2019-10-23

Alliance Glenoid

Applicant Zimmer, Inc.

K number K191814

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KWS 2019-07-08

Materialise Glenoid Positioning System

Applicant Materialise NV

K number K190286

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KWS 2019-06-14

AEQUALIS FLEX REVIVE Shoulder System

Applicant Tornier, Inc.

K number K191318

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KWS 2019-06-12

Aequalis Ascend Flex Shoulder System

Applicant Tornier S.A.S.

K number K190521

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KWS 2019-04-26

AltiVate Reverse Humeral Stem, 48mm

Applicant Encore Medical L.P.

K number K190290

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KWS 2019-03-08

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

Applicant Arthrex, Inc.

K number K182799

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KWS 2019-02-15

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K number K183039

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KWS 2019-01-25

SMR Lateralized Connectors with screws

Applicant Lima Corporate S.P.A.

K number K183042

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KWS 2018-12-21

Arthrex Fracture Adapter Hemi Shoulder Prosthesis

Applicant Arthrex, Inc.

K number K181555

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KWS 2018-09-27

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K number K181742

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KWS 2018-09-20

Aequalis Flex Revive Shoulder System

Applicant Tornier, Inc.

K number K181420

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KWS 2018-03-29

Arthrex Shoulder System

Applicant Arthrex, Inc.

K number K171841

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KWS 2017-11-03

Materialise Glenoid Positioning System

Applicant Materialise NV

K number K172054

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KWS 2017-10-30

AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

Applicant Encore Medical L.P.

K number K172351

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KWS 2017-10-02

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker Trauma AG

K number K172210

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KWS 2017-08-16

Medacta Anatomic Shoulder Prosthesis

Applicant Medacta International S.A.

K number K170910

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KWS 2017-06-19

Materialise Glenoid Positioning System

Applicant Materialise NV

K number K170893

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KWS 2017-02-22

BLUEPRINT Patient Specific Instrumentation

Applicant Tornier S.A.S.

K number K162800

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KWS 2017-02-10

Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

Applicant Custom Orthopaedic Solutions, Inc.

K number K162697

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KWS 2016-12-27

BLUEPRINT Patient Specific Instrumentation

Applicant Tornier S.A.S.

K number K161789

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KWS 2016-11-23

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)

Applicant Stryker GmbH

K number K161863

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KWS 2016-11-21

AltiVate Anatomic Shoulder System

Applicant Encore Medical L.P.

K number K162024

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KWS 2016-08-29

Arthrex VaultLock Glenoid

Applicant Arthrex, Inc.

K number K161108

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KWS 2016-06-10

Aequalis PerFORM+ Shoulder System

Applicant Tornier, Inc.

K number K160975

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KWS 2016-06-10

BLUEPRINT Patient Specific Instrumentation

Applicant Tornier S.A.S.

K number K160555

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KWS 2016-04-26

Materialise Glenoid Positioning System

Applicant Materialise NV

K number K153602

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KWS 2016-04-06

SMR 3-Pegs Glenoids

Applicant Lima Corporate S.P.A.

K number K153722

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KWS 2016-03-08

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System

Applicant Zimmer GmbH

K number K160085

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KWS 2016-02-19

SmartBase for Arthrex Glenoid IRIS

Applicant Custom Orthopaedic Solutions, Inc.

K number K153215

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KWS 2013-10-29

REVERSE SHOULDER PROSTHESIS MONOBLOCK

Applicant Encore Medical L.P.

K number K130048

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KWS 2013-09-27

ARTHREX UNIVERS APEX

Applicant Arthrex, Inc.

K number K131633

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KWS 2013-09-27

MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES

Applicant Materialise NV

K number K131559

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KWS 2013-08-28

SEVIIN FRACTURE SHOULDER

Applicant Ingen Orthopedics, LLC

K number K131277

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KWS 2013-08-20

CAS PSI SHOULDER

Applicant Zimmer Cas

K number K131129

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KWS 2013-06-18

TITAN REVERSE SHOULDER SYSTEM

Applicant Ascension Orthopedic

K number K130050

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KWS 2013-06-12

SMR 3-PEGS GLENOIDS

Applicant Lima Corporate S.P.A.

K number K130642

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KWS 2013-06-07

LIMACORPORATE SMR CTA HUMERAL HEADS

Applicant Lima Corporate S.P.A.

K number K131112

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KWS 2013-05-31

UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM

Applicant Arthrex, Inc.

K number K130129

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KWS 2013-04-05

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

Applicant Cleveland Clinic

K number K123122

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KWS 2013-01-23

TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+

Applicant Encore Medical L.P.

K number K123982

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KWS 2013-01-08

AEQUALIS ASCEND FLEX SHOULDER SYSTEM

Applicant Tornier S.A.S.

K number K122698

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KWS 2012-11-20

EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT

Applicant Exactech, Inc.

K number K121220

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KWS 2012-06-20

ASCEND SHOULDER SYSTEM

Applicant Tornier, Inc.

K number K121493

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KWS 2012-04-13

ASCEND SHOULDER SYSTEM

Applicant Tornier, Inc.

K number K120794

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KWS 2012-04-11

TITAN MODULAR TOTAL SHOULDER SYSTEM

Applicant Ascension Orthopedic

K number K112438

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KWS 2012-03-09

ASCEND SHOULDER SYSTEM

Applicant Tornier, Inc.

K number K113413

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KWS 2012-03-08

ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED

Applicant Arthrex, Inc.

K number K120044

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KWS 2012-01-05

PROMOS MODULAR SHOULDER SYSTEM

Applicant Smith & Nephew, Inc.

K number K113012

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KWS 2011-12-08

EXACTECH EQUINOXE CAGE GLENOIDS

Applicant Exactech, Inc.

K number K113309

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KWS 2011-11-03

AEQUALIS SHOULDER SYSTEM

Applicant Tornier

K number K111902

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KWS 2011-07-28

SMR SHOULDER SYSTEM- REVISION STEMS

Applicant Lima Corporate S.P.A.

K number K111212

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KWS 2011-07-15

SMR SHOULDER SYSTEM - CTA HUMERAL HEADS

Applicant Lima Corporate S.P.A.

K number K110847

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KWS 2011-07-05

TOTAL SHOULDER SYSTEM

Applicant Shoulder Innovations, LLC

K number K111596

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KWS 2011-06-08

EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT

Applicant Exactech, Inc.

K number K111379

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KWS 2011-05-24

TOTAL SHOULDER SYSTEM

Applicant Shoulder Innovations, LLC

K number K110905

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KWS 2011-05-05

REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N

Applicant Howmedica Osteonics Corp.

K number K103835

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KWS 2011-04-27

AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

Applicant Tornier, Inc.

K number K110865

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KWS 2011-01-31

AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

Applicant Tornier, Inc.

K number K102924

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KWS 2011-01-24

TOTAL SHOULDER SYSTEM

Applicant Shoulder Innovations, LLC

K number K102670

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KWS 2010-12-22

ARTHREX UNIVERS II SHOULDER PROSTHESIS

Applicant Arthrex, Inc.

K number K103466

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KWS 2010-12-13

EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM

Applicant Exactech, Inc.

K number K103419

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KWS 2010-11-24

ARROW ANATOMICAL SHOULDER SYSTEM

Applicant Fournitures Hospitalieres Industrie

K number K093599

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KWS 2010-11-22

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT

Applicant Howmedica Osteonics Corp.

K number K103104

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KWS 2010-11-09

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

Applicant Tornier, Inc.

K number K103007

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KWS 2010-09-02

EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.

Applicant Exactech, Inc.

K number K093430

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KWS 2010-08-30

ASCENSION MODULAR TOTAL SHOULDER SYSTEM

Applicant Ascension Orthopedics, Inc.

K number K100448

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KWS 2009-10-27

GRS GLENOID RESURFACING SYSTEM

Applicant Arthrosurface, Inc.

K number K091196

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KWS 2009-07-27

GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID

Applicant DePuy Orthopaedics, Inc.

K number K092122

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KWS 2009-07-14

DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP

Applicant DePuy Orthopaedics, Inc.

K number K091751

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KWS 2009-06-26

ARTHREX UNIVERS II SHOULDER PEGGED GLENOID

Applicant Arthrex, Inc.

K number K083435

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KWS 2008-10-24

AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS

Applicant Tornier

K number K082120

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KWS 2008-07-17

AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS

Applicant Tornier, Inc.

K number K081707

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KWS 2008-06-30

MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K081620

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KWS 2008-03-28

ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38

Applicant Encore Medical L.P.

K number K080402

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KWS 2007-08-20

ARTHREX UNIVERS II SHOULDER PROSTHESIS

Applicant Arthrex, Inc.

K number K071032

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