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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 1995-07-05

ORTHOPEDIC BONE PLATE

Applicant Osteomed Corp.

K number K932352

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HRS 1995-06-22

LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW

Applicant Howmedica Corp.

K number K951415

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HRS 1995-06-12

LUHR TITANIUM PAN FIXATION SYSTEM

Applicant Howmedica Corp.

K number K945139

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HRS 1995-06-12

LUHR TITANIUM ALLOY PAN FIXATION SYSTEM

Applicant Howmedica Corp.

K number K945137

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HRS 1995-05-23

CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM

Applicant Elekta Instruments, Inc.

K number K946165

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HRS 1995-05-16

ORTHOMET ACETABULAR ROOF REINFORCEMENT RING

Applicant Wrightmedicaltechnologyinc

K number K944856

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HRS 1995-05-10

ACE SUPRACONDYLAR PLATE

Applicant Ace Medical Co.

K number K950618

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HRS 1995-04-13

BONE PLATE SYSTEM

Applicant Acu Med, Inc.

K number K942359

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HRS 1995-04-10

LUHR(R) TITANIUM BURR HOLE COVERS

Applicant Howmedica, Inc.

K number K950115

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HRS 1995-04-10

LUHR(R) TITANIUM ALLOY BURR HOLE COVERS

Applicant Howmedica Corp.

K number K950105

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HRS 1995-01-20

DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K943853

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HRS 1994-08-01

PELVIC RADIUS PLATE

Applicant Smith & Nephew Richards, Inc.

K number K936233

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HRS 1994-06-15

VARIABLE ANGULAR HOLD BONE PLATE SYSTEM

Applicant Smith & Nephew Richards, Inc.

K number K930480

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HRS 1994-06-07

SPOON PLATE

Applicant Onyx Medical Corp.

K number K931690

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HRS 1994-05-04

MINI FRAGMENT PLATE

Applicant Onyx Medical Corp.

K number K934614

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HRS 1994-05-04

T-PLATE

Applicant Onyx Medical Corp.

K number K931692

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HRS 1994-05-04

EPIPHYSIS PLATE

Applicant Onyx Medical Corp.

K number K931684

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HRS 1994-04-25

1/4 TUBULAR PLATE

Applicant Onyx Medical Corp.

K number K931694

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HRS 1994-04-25

1/3 TUBULAR PLATE

Applicant Onyx Medical Corp.

K number K931693

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HRS 1994-04-25

STRAIGHT MINI-PLATE

Applicant Onyx Medical Corp.

K number K931691

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HRS 1994-04-25

SMALL STRAIGHT PLATE

Applicant Onyx Medical Corp.

K number K931689

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HRS 1994-04-25

SEMI-TUBULAR PLATE

Applicant Onyx Medical Corp.

K number K931688

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HRS 1994-04-25

MULTIPLE FRAGMENT PLATE

Applicant Onyx Medical Corp.

K number K931687

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HRS 1994-04-25

FOREARM SELF COMPRESSION PLATE

Applicant Onyx Medical Corp.

K number K931685

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HRS 1994-04-25

CLOVERLEAF PLATE

Applicant Onyx Medical Corp.

K number K931683

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HRS 1994-04-25

BUTTRESS PLATE

Applicant Onyx Medical Corp.

K number K931679

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HRS 1994-04-25

BAUMER PLATES

Applicant Baumer Ortopedia , Ltd.

K number K930966

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HRS 1994-02-23

LUHR MINI BONE SCREW AND Z PLATE

Applicant Howmedica Corp.

K number K935448

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HRS 1994-02-17

ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES

Applicant Alphatec Mfg., Inc.

K number K933112

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HRS 1994-02-15

BONE PLATE

Applicant Acu Med, Inc.

K number K931244

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HRS 1993-07-26

ACE UNIVERSAL RECONSTRUCTION PLATE

Applicant Ace Medical Co.

K number K930592

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HRS 1993-07-13

OTI EUROPEAN COMPRESSION SYSTEM

Applicant Osteo-Technology Intl., Inc.

K number K925571

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HRS 1993-04-14

ALPHATEC 130 COMPRESSION HIP SCREW

Applicant Alphatec Mfg., Inc.

K number K925500

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HRS 1993-03-04

LUHR PAN FIXATION SYSTEM

Applicant Howmedica Corp.

K number K923861

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HRS 1993-02-10

ANSPACH MINI-PLATING SYSTEM

Applicant The Anspach Effort, Inc.

K number K921338

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HRS 1992-12-17

RECONSTRUCTION PLATE SYSTEM

Applicant Sofamor Danek Mfg., Inc.

K number K924085

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HRS 1992-09-22

DALL MILES BROAD BONE PLATE

Applicant Howmedica Corp.

K number K922525

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HRS 1992-08-06

ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES

Applicant Alphatec Mfg., Inc.

K number K922167

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HRS 1992-07-27

ACE 100 DEGREES TUBULAR PLATE

Applicant Ace Orthopedic Manufacturing Co.

K number K920738

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HRS 1992-07-17

TMP MICROPLATING SYSTEM

Applicant Techmedica, Inc.

K number K921458

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HRS 1992-07-02

ALPHATEC COMPRESSION HIP SCREW SYSTEM

Applicant Alphatec Mfg., Inc.

K number K921622

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HRS 1992-06-02

MICROAIRE(R) FACIAL BONE PLATING SYSTEM

Applicant Micro Surgical Instruments Corp.

K number K914998

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HRS 1992-04-29

RADIUS OSTEOTOMY PLATES

Applicant Link America, Inc.

K number K914804

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HRS 1992-04-28

SCHWABE RADIUS PLATES

Applicant Link America, Inc.

K number K914803

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HRS 1992-02-20

AAP BONE PLATE

Applicant Aap International, Ltd.

K number K915315

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HRS 1992-01-17

SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE

Applicant Synthes (Usa)

K number K915818

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HRS 1991-12-02

LUHR PAN FIXATION SYSTEM

Applicant Howmedica Corp.

K number K913355

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HRS 1991-10-17

OSTEO BONE PLATED

Applicant Fred C. Bryson

K number K913271

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HRS 1991-10-04

FIXATION DEVICES AND BONE PLATE

Applicant John M. Rayhack

K number K913930

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HRS 1991-09-25

SYNTHES MAXILLOFACIAL TITANIUM MICRO SET

Applicant Synthes (Usa)

K number K912932

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HRS 1991-09-06

MAY HUMERUS PLATES

Applicant Turnkey Intergration USA, Inc.

K number K912936

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HRS 1991-09-05

MASTERPIECES(TM)/MICRO/MINI SYSTEMS

Applicant Storz Instrument Co.

K number K913289

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HRS 1991-07-30

ALTA CHANNEL PLATE CONNECTOR

Applicant Howmedica Corp.

K number K910482

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HRS 1991-07-26

MASTERPIECES MICRO SYSTEM

Applicant Storz Instrument Co.

K number K910957

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HRS 1991-06-24

TMP MANDIBULAR COMPRESSION SYSTEM

Applicant Techmedica, Inc.

K number K905024

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HRS 1991-06-21

FIXATION DEVICES AND BONE PLATE

Applicant Micro Surgical Instruments Corp.

K number K910175

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HRS 1991-06-13

THACKRAY TITANIUM MINI-PLATING SYSTEM

Applicant Depuy, Inc.

K number K905774

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HRS 1991-03-14

ACE RECONSTRUCTIVE PLATE

Applicant Ace Medical Co.

K number K905595

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HRS 1991-01-15

HAWAIIAN SUPRACONDYLAR PLATE

Applicant Medpac

K number K903697

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HRS 1991-01-04

BROAD SELF-COMPRESSING PLATE

Applicant O'Tec Corp.

K number K905355

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HRS 1990-08-10

BARNES FEMORAL LENGTHENING DEVICE

Applicant Piedmont Sports Medicine & Orthopaedic Clinic

K number K895243

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HRS 1990-08-09

BROAD SELF-COMPRESSING PLATE

Applicant Onyx Medical Corp.

K number K903252

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HRS 1990-04-04

BONE PLATE

Applicant Karlin Technology, Inc.

K number K893201

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HRS 1989-10-06

INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM

Applicant Intermedics Orthopedics

K number K892228

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HRS 1989-05-22

DUPONT DISTAL HUMERAL NAIL

Applicant Howmedica Corp.

K number K890939

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HRS 1989-02-27

ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES

Applicant Acufex Microsurgical, Inc.

K number K890641

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HRS 1989-02-13

ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS

Applicant Howmedica Corp.

K number K885250

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HRS 1988-08-19

LUHR MICRO SYSTEM

Applicant Howmedica Corp.

K number K882454

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HRS 1988-01-14

ORTHOMET BONE PLATES

Applicant Orthomet, Inc.

K number K875086

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HRS 1987-09-01

TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS

Applicant Techmedica, Inc.

K number K873005

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HRS 1987-05-06

BONE PLATE

Applicant Terray Manufacturing, Inc.

K number K870082

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HRS 1987-04-03

HOFFMANN LEG LENGTHENING PLATE SYSTEM

Applicant Howmedica Corp.

K number K870388

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HRS 1987-03-20

KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM

Applicant Kirschner Medical Corp.

K number K864924

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HRS 1986-07-08

WARSAW ORTHOPEDIC BONE PLATE

Applicant Warsaw Orthopedic, Inc.

K number K862254

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HRS 1986-03-13

SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION

Applicant 3M Company

K number K860600

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HRS 1986-03-10

ACE MULTIPLE PIN PLATE

Applicant Buckman Co., Inc.

K number K860591

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HRS 1986-01-21

LINK SMALL BONE PLATES

Applicant Link America, Inc.

K number K854825

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HRS 1985-11-15

A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM

Applicant Downs Surgical , Ltd.

K number K853709

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HRS 1985-05-20

ORTHOPEDIC IMPLANT PLATES

Applicant Kirkstil Corp., Inc.

K number K850025

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HRS 1985-04-19

MEC BUTRESS PLATE

Applicant Pfizer, Inc.

K number K850444

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HRS 1985-04-19

MEC BROAD BONE PLATE

Applicant Pfizer, Inc.

K number K850442

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HRS 1985-04-19

LETOURNEL ACETABULAR PLATE

Applicant Pfizer, Inc.

K number K850401

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HRS 1985-01-23

IMSI/METRIPOND GRIPPER PLATE

Applicant Intl. Management Services, Inc.

K number K843370

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HRS 1984-05-11

DYNAMIC CONDYLAR SCREW OR D.C.S.

Applicant Synthes (Usa)

K number K840954

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HRS 1983-12-12

ACE BROOKER BONE PLATING SYSTEM

Applicant Buckman Co., Inc.

K number K833865

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HRS 1981-06-23

CRYOPHTHALMIC UNIT

Applicant Keeler Instruments, Inc.

K number K811244

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HRS 1981-01-23

CURVED SHERMAN BONE PLATE

Applicant Howmedica Corp.

K number K810061

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HRS 1981-01-09

INTEROOM(POWERED OPHTHALMIC TABLE)

Applicant Jocevest Interoom, Inc.

K number K803176

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HRS 1980-10-03

POLYETHYLENE FILLED BONE PLATE

Applicant Zimmer, Inc.

K number K801603

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HRS 1980-04-21

I.C.S. MINI & SMALL FRAGMENT SET

Applicant Howmedica Corp.

K number K800806

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HRS 1980-04-02

ADDITIONAL COMPONENTS KRONNER COMPRES

Applicant Richard F. Kronner, M.D.

K number K800502

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HRS 1979-01-10

MULTIPLICITY OF PRODUCTS

Applicant Depuy, Inc.

K number K782123

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HRS 1977-01-26

B.G. COMPRESSION SYSTEM

Applicant Howmedica Corp.

K number K770128

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HRS 1976-12-16

GALLENAUGH BONE PLATES

Applicant Orthopedic Equipment Co., Inc.

K number K761150

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