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Nail, Fixation, Bone

FDA product code JDS · 52 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: 1977-01-26 – 2025-06-12

JDS 2025-06-12

TRIGEN Stable Lock Nut & Washer

Applicant Smith & Nephew, Inc.

K number K243608

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JDS 2024-09-20

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

Applicant Smith & Nephew, Inc.

K number K240061

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JDS 2024-08-22

TRIGEN INTERTAN 10S Nail System

Applicant Smith & Nephew, Inc.

K number K241804

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JDS 2024-02-20

NET BRAND Osteosynthesis Nailing System

Applicant Narang Medical , Ltd.

K number K233150

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JDS 2023-06-14

TRIGEN META-NAIL Nail System

Applicant Smith & Nephew, Inc.

K number K230761

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JDS 2020-09-03

DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm

Applicant Synthes (USA) Products, LLC

K number K201336

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JDS 2020-06-10

Auxein Nailing System

Applicant Auxein Medical Private Limited

K number K192003

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JDS 2020-02-20

WIN Flexible Nail System

Applicant Biomet, Inc.

K number K193533

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JDS 2013-03-14

CHINA NAILS AND ACCESSORIES

Applicant Smith & Nephew, Inc.

K number K123948

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JDS 2011-12-05

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

Applicant Synthes (Usa)

K number K111667

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JDS 2008-06-09

CONNEXX LOCKING TIBIA NAIL

Applicant I.T.S. Implantat-Technologie-Systeme GmbH

K number K080706

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JDS 2007-09-27

SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS

Applicant Synthes (Usa)

K number K072095

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JDS 2007-03-13

SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM

Applicant Synthes (Usa)

K number K062872

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JDS 2006-08-10

KNEE FUSION NAIL

Applicant Smith & Nephew, Inc.

K number K061783

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JDS 2006-06-06

TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS

Applicant Smith & Nephew, Inc.

K number K061019

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JDS 2005-06-30

TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS

Applicant Smith & Nephew, Inc.

K number K051557

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JDS 2005-05-04

KNEE FUSION NAIL

Applicant Smith & Nephew, Inc.

K number K050938

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JDS 2004-04-12

SYNTHES (USA) TIBIAL NAIL SYSTEM EX

Applicant Synthes (Usa)

K number K040762

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JDS 2004-02-20

TRIGEN INTERTAN

Applicant Smith & Nephew, Inc.

K number K040212

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JDS 2003-11-05

SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM

Applicant Synthes (Usa)

K number K033071

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JDS 2003-10-06

NORMED COMPRESSION BONE SCREW SYSTEM

Applicant Noviace Corporation

K number K032634

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JDS 2002-08-26

BNF

Applicant Aap Implantate AG

K number K021782

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JDS 2002-03-21

ODI TALON INTRAMEDULLARY HIP NAIL

Applicant Orthopedic Designs, Inc.

K number K014189

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JDS 2001-08-14

BAUMER LOCKING NAIL

Applicant Baumer, S.A

K number K011504

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JDS 2000-12-28

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

Applicant Disco-O-Tech Medical Technologies, Ltd.

K number K003212

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JDS 2000-12-27

MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

Applicant Disco-O-Tech Medical Technologies, Ltd.

K number K003215

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JDS 2000-10-30

WUJIN #3 TIBIAL NAIL

Applicant Biologically Oriented Prostheses

K number K002325

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JDS 2000-10-06

SYNTHES PROXIMAL HUMERAL NAIL

Applicant Synthes (Usa)

K number K002729

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JDS 2000-04-06

PEDIATRIC FIXATION RODS

Applicant Biomet, Inc.

K number K000764

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JDS 1999-10-06

ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW

Applicant Howmedica Osteonics Corp.

K number K993004

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JDS 1999-09-23

SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)

Applicant Synthes (Usa)

K number K992348

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JDS 1999-08-06

MACMED PAEDIATRIC INTRAMEDULLARY NAIL

Applicant Innervision, Inc.

K number K991877

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JDS 1999-06-23

EUCLID REDUCTION AND GUIDANCE SYSTEM

Applicant Modular Cutting Systems, Inc.

K number K991037

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JDS 1998-12-04

INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP

Applicant Smith & Nephew, Inc.

K number K983942

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JDS 1998-07-09

TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW

Applicant Smith & Nephew, Inc.

K number K981529

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JDS 1997-09-04

SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM

Applicant Synthes (Usa)

K number K972516

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JDS 1996-07-24

TITANIUM CANNULATED TIBIAL NAIL (TI CTN)

Applicant Synthes (Usa)

K number K962047

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JDS 1995-07-12

BONE FIXATION NAIL

Applicant Acu Med, Inc.

K number K943855

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JDS 1995-05-05

SMALL FRAGMENT PLATES AND SCREWS

Applicant Medpac

K number K951302

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JDS 1994-09-12

HAIG NAIL

Applicant Howmedica Corp.

K number K940736

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JDS 1993-08-25

FEMORAL INTRAMEDULLARY RODS

Applicant Applied Osteo Systems, Inc.

K number K926465

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JDS 1992-11-23

SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS

Applicant Howmedica Corp.

K number K924004

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JDS 1992-02-18

UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL

Applicant Synthes (Usa)

K number K914453

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JDS 1992-02-18

UNIVERSAL FEMORAL NAIL

Applicant Synthes (Usa)

K number K914371

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JDS 1989-01-30

HUMERAL LOCKING NAIL SYSTEM

Applicant Howmedica Corp.

K number K883882

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JDS 1988-11-28

TRACER HIP PINNING SYSTEM

Applicant De Medica Mfg., Inc.

K number K884406

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JDS 1984-05-30

POLY PLUG CEMENT RESTRICTOR

Applicant Latham Manufacturer

K number K840242

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JDS 1983-10-20

INTRAMEDULLARY BONE PLUG

Applicant Kirschner Medical Corp.

K number K832328

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JDS 1980-05-02

SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K800898

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JDS 1980-02-19

FEMORAL CEMENT RESTRICTOR

Applicant Biomet, Inc.

K number K800144

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JDS 1980-02-19

FUSON BONE PLUG, RADIOPAQUE

Applicant Zimmer, Inc.

K number K800142

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JDS 1977-01-26

B.G. FLEXIBLE NAIL SYSTEM

Applicant Howmedica Corp.

K number K770130

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