Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Plate, Fixation, Bone

FDA product code HRS · 1194 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3030
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-16 – 2026-09-23

HRS 2001-11-07

CONGRUENT BONE PLATE SYSTEM

Applicant Acu Med, Inc.

K number K012655

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HRS 2001-09-28

SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM

Applicant Synthes (Usa)

K number K012114

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HRS 2001-08-31

STRYKER PLATING SYSTEM BASIC FRAGMENT SET

Applicant Howmedica Osteonics Corp.

K number K012162

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HRS 2001-08-09

SYNTHES LCP PROXIMAL TIBIA PLATE

Applicant Synthes (Usa)

K number K011978

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HRS 2001-08-07

WUJIN #3 TIBIAL BONE PLATE

Applicant Biopro, Inc.

K number K011460

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HRS 2001-08-07

WUJIN #3 FEMORAL BONE PLATE

Applicant Biopro, Inc.

K number K011459

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HRS 2001-07-31

HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

Applicant Dj Orthopedics, LLC

K number K011354

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HRS 2001-07-27

SYNTHS ONE-THIRD TUBULAR DCL PLATE

Applicant Synthes (Usa)

K number K011335

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HRS 2001-07-27

SYNTHES CURVED RECONSTRUCTION PLATE

Applicant Synthes (Usa)

K number K011334

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HRS 2001-07-20

NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM

Applicant Osteomedics

K number K011118

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HRS 2001-07-16

LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW

Applicant Walter Lorenz Surgical, Inc.

K number K011076

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HRS 2001-07-05

SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE

Applicant Synthes (Usa)

K number K011170

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HRS 2001-05-30

SYNTHES RESORABLE MESHES AND SHEETS

Applicant Synthes (Usa)

K number K003788

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HRS 2001-05-23

LACTOSORB PLATES, MESHES, AND PANELS/SHEETS

Applicant Biomet, Inc.

K number K011237

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HRS 2000-12-05

DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM

Applicant Hand Innovations, Inc.

K number K002775

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HRS 2000-11-24

COD COMPRESSION OSTEOTOMY DEVICE

Applicant Walter Abendschein, M.D.

K number K002184

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HRS 2000-11-09

PRECIMED TRAUMA SYSTEM

Applicant Patrick Berdoz

K number K002486

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HRS 2000-11-06

PE.R.I. II KNEE FRACTURE SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K003235

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HRS 2000-10-31

SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM

Applicant Synthes (Usa)

K number K002361

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HRS 2000-09-29

MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)

Applicant Synthes (Usa)

K number K002710

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HRS 2000-09-22

SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

Applicant Synthes (Usa)

K number K001945

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HRS 2000-09-22

SYNTHES MODULAR FOOT SYSTEM

Applicant Synthes (Usa)

K number K001941

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HRS 2000-08-07

LACTOSORB PANELS AND FASTENERS

Applicant Biomet, Inc.

K number K984390

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HRS 2000-07-24

MACROSORBOS PROTECTIVE SHEET

Applicant Macropore Biosurgery, Inc.

K number K994158

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HRS 2000-06-20

SYNTHES (USA) ORIBITAL MESH PLATES

Applicant Synthes (Usa)

K number K001311

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HRS 2000-05-11

STRYKER TRAUMA PLATING SYSTEM

Applicant Howmedica Osteonics Corp.

K number K000636

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HRS 2000-03-15

SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM

Applicant Synthes (Usa)

K number K000066

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HRS 2000-02-14

LOCON-T DISTAL RADIAL PLATE

Applicant Wrightmedicaltechnologyinc

K number K994061

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HRS 2000-01-11

DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE

Applicant Depuy, Inc.

K number K993465

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HRS 1999-12-20

LACTOSORB TRAUMA PLATING SYSTEM

Applicant Biomet, Inc.

K number K992355

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HRS 1999-12-09

SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)

Applicant Smith & Nephew, Inc.

K number K993106

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HRS 1999-11-16

MODIFIED BMP TROCHANTERIC PLATES

Applicant Biomet, Inc.

K number K993510

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HRS 1999-11-08

LORENZ SMALL FRAGMENT SYSTEM

Applicant Walter Lorenz Surgical, Inc.

K number K992961

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HRS 1999-08-17

KMI WRIST FUSION SYSTEM

Applicant Kinetikos Medical, Inc.

K number K991873

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HRS 1999-07-30

LACTOSORB HAND SYSTEM

Applicant Biomet, Inc.

K number K991763

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HRS 1999-04-29

DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM

Applicant Avanta Orthopaedics, Inc.

K number K990596

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HRS 1999-03-23

DEPUY ACE SPIDER PLATE

Applicant Depuy Ace Medical Co.

K number K990392

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HRS 1999-03-17

ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM

Applicant Biodynamic Technologies, Inc.

K number K990481

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HRS 1999-02-18

KMI WRIST FUSION SYSTEM

Applicant Kinetikos Medical, Inc.

K number K990094

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HRS 1999-01-27

SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE

Applicant Syntec Scientific Corp.

K number K983988

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HRS 1999-01-21

SYNTHES PROXIMAL TIBIA PLATING SYSTEM

Applicant Synthes (Usa)

K number K983787

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HRS 1998-12-31

DEPUY ACE SPIDER PLATE

Applicant Depuy Ace Medical Co.

K number K984458

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HRS 1998-12-22

DEPUY ACE TIMAX META PLATE

Applicant Depuy Ace Medical Co.

K number K983853

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HRS 1998-12-16

PEDIATRIC CANNULATED OSTEOTOMY PLATES

Applicant Biomet, Inc.

K number K983967

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HRS 1998-12-04

COBRA EXTERNAL FIXATOR

Applicant Orthopaedic Innovations, Inc.

K number K983881

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HRS 1998-11-25

HOFFMANN II MIAMI POST

Applicant Howmedica Corp.

K number K983419

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HRS 1998-10-16

HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM

Applicant Howmedica Corp.

K number K982531

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HRS 1998-10-13

MINI-FIXATOR FOR COLLES FRACTURES

Applicant Biomet, Inc.

K number K982982

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HRS 1998-10-08

SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)

Applicant Synthes

K number K982732

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HRS 1998-09-22

OSTEO COMPRESSION HIP SCREW SYSTEM

Applicant Osteonics Corp.

K number K982553

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HRS 1998-09-14

DEPUY MOTECH PEAK FIXATION SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K982483

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HRS 1998-08-31

DEPUY ACE TIMAX PILON PLATE

Applicant Depuy Ace Medical Co.

K number K982347

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HRS 1998-07-30

MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)

Applicant Pacific Materials and Interfaces

K number K972913

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HRS 1998-07-29

DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE

Applicant Depuy Ace Medical Co.

K number K981775

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HRS 1998-07-29

DISTAL RADIUS FRACTURE FIXATION PLATE

Applicant Avanta Orthopaedics, Inc.

K number K981715

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HRS 1998-07-13

LORENZ PECTUS SUPPORT BAR STABILIZER

Applicant Walter Lorenz Surgical, Inc.

K number K981789

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HRS 1998-06-10

ROGACHEFSKY DISTAL RADIUS PLATES

Applicant Howmedica, Inc.

K number K981283

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HRS 1998-06-10

ARTHREX PUDDU OSTEOTOMY SYSTEM

Applicant Arthrex, Inc.

K number K973812

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HRS 1998-04-14

DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM

Applicant Depuy, Inc.

K number K980368

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HRS 1998-03-18

SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES

Applicant Synthes (Usa)

K number K974908

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HRS 1998-03-10

PLAQUAGRAFE, AGRAFE P4V

Applicant Atlas Technology

K number K974603

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HRS 1998-02-12

EPI-UNION PLATING SYSTEM

Applicant Howmedica, Inc.

K number K974289

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HRS 1998-01-30

LACTOSORB PANELS

Applicant Biomet, Inc.

K number K974309

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HRS 1998-01-21

CARPAL ENGAGING WRIST FUSION PLATE

Applicant Terray Corp.

K number K974030

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HRS 1998-01-16

TIMESH SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K974017

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HRS 1998-01-12

ORBITAL RECONSTRUCTION PLATES

Applicant Howmedica, Inc.

K number K973982

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HRS 1997-12-09

OSTEO BOS SYSTEM PRODUCT LINE EXTENSION

Applicant Osteonics Corp.

K number K973438

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HRS 1997-11-20

ORTHOPEDIC PLATE SYSTEM

Applicant Ferguson Medical

K number K972219

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HRS 1997-09-25

OSTEO BOS SYSTEM IN STAINLESS STEEL

Applicant Osteonics Corp.

K number K973204

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HRS 1997-09-11

ALTA PLATING SYSTEM

Applicant Howmedica Corp.

K number K972479

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HRS 1997-09-10

OSTEO BOS SYSTEM

Applicant Osteonics Corp.

K number K972323

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HRS 1997-09-10

BONE PLATE WITH CABLES

Applicant Pioneer Surgical Technology

K number K972223

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HRS 1997-08-25

OSTEO ANATOMICAL BONE PLATES

Applicant Osteonics Corp.

K number K972196

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HRS 1997-08-19

LACTOSORB TRAUMA PLATING SYSTEM

Applicant Biomet, Inc.

K number K971870

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HRS 1997-08-11

LORENZ PECTUS SUPPORT BAR

Applicant Walter Lorenz Surgical, Inc.

K number K972420

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HRS 1997-07-17

EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES

Applicant Howmedica Leibinger, Inc.

K number K961719

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HRS 1997-07-09

OSTEO COMPRESSION CONDYLE SCREW SYSTEM

Applicant Osteonics Corp.

K number K971321

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HRS 1997-05-22

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES

Applicant Ferguson Medical

K number K970258

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HRS 1997-05-08

CENTRE-DRIVE DRILL-FREE SCREW

Applicant KLS-Martin L.P.

K number K971297

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HRS 1997-04-30

DEPUY ACE TROCHANTERIC SIDE PLATE

Applicant Depuy Ace Medical Co.

K number K970503

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HRS 1997-03-25

SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM

Applicant Synthes (Usa)

K number K963325

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HRS 1997-02-12

METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM

Applicant Metagen, LLC

K number K963700

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HRS 1997-02-06

LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS

Applicant Howmedica Leibinger, Inc.

K number K963741

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HRS 1997-02-06

RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)

Applicant Howmedica, Inc.

K number K961498

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HRS 1997-01-16

KINAMED PROFIX SYSTEM

Applicant Kinamed, Inc.

K number K964362

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HRS 1996-12-17

SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM

Applicant Synthes (Usa)

K number K962894

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HRS 1996-11-27

SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM

Applicant Synthes (Usa)

K number K963798

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HRS 1996-09-03

SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM

Applicant Synthes (Usa)

K number K962616

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HRS 1996-06-28

PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM

Applicant Howmedica, Inc.

K number K961497

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HRS 1996-06-28

R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM

Applicant Howmedica, Inc.

K number K961496

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HRS 1996-06-13

PLAMP, PLAMP PLATE, PLAMP WITH HOOK

Applicant Hospital For Special Surgery

K number K942032

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HRS 1996-06-01

FOREFOOT RECONSTRUCTION SYSTEM

Applicant Howmedica Corp.

K number K961485

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HRS 1996-04-10

LACTOSORB TRAUMA PLATING SYSTEM

Applicant Poly-Medics,Inc.

K number K960988

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HRS 1996-04-01

ACE HUMERUS & RADIUS PLATES

Applicant Ace Medical Co.

K number K955472

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HRS 1996-03-22

SCHUHLI IMPLANT SYSTEM

Applicant Synthes (Usa)

K number K954963

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HRS 1996-03-08

VOLAR DISTAL RADIUS PLATE

Applicant Synthes (Usa)

K number K953644

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HRS 1996-02-14

LACTOSORB TRAUMA PLATING SYSTEM

Applicant Poly-Medics,Inc.

K number K955729

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HRS 1995-12-13

RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)

Applicant Creative Medical Designs, Inc.

K number K952766

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HRS 1995-11-20

ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE

Applicant Zimmer, Inc.

K number K953714

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HRS 1995-07-05

LINK ENDO MODEL REVISION CUP

Applicant Turnkey Intergration USA, Inc.

K number K943986

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