Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

FDA product code KTW · 38 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: 1978-12-20 – 2019-06-20

KTW 2019-06-20

PK High Tibial Osteotomy Correction System

Applicant Paonan Biotech Co., Ltd.

K number K182285

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KTW 2017-06-22

AOS Anterolateral Proximal Humeral Plate

Applicant Advanced Orthopaedic Solutions, Inc. (Aos)

K number K171606

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KTW 2017-06-19

Phantom Small Bone Intramedullary Nail System

Applicant Paragon 28, Inc.

K number K170693

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KTW 2016-03-15

AOS Anterolateral Proximal Humeral Plate

Applicant Advanced Orthopaedic Solutions, Inc.

K number K160409

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KTW 2012-09-20

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)

Applicant Orthofix Srl

K number K122541

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KTW 2008-05-06

AOS PROXIMAL HUMERAL PLATE

Applicant Advanced Orthopaedic Solutions, Inc.

K number K080590

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KTW 2008-03-20

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM

Applicant Synthes (Usa)

K number K080109

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KTW 2006-11-13

ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP

Applicant Orthofix Srl

K number K062920

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KTW 2002-10-25

LEFORTE SYSTEM BONE PLATE

Applicant Jeil Medical Corporation

K number K023360

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KTW 2002-06-24

REPROCESSED EBI EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K012645

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KTW 2002-06-24

REPROCESSED EXTERNAL FIXATION DEVICE

Applicant Alliance Medical, Inc.

K number K012634

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KTW 2001-09-06

SYNTHES LCP PROXIMAL HUMERUS PLATES

Applicant Synthes (Usa)

K number K011815

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KTW 2001-08-02

SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM

Applicant Synthes (Usa)

K number K011458

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KTW 2001-05-02

MODULAR FOOT SYSTEM - 2.7 MM MODULE

Applicant Synthes (Usa)

K number K010321

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KTW 2000-08-04

STRYKER TRAUMA PELVIC SET

Applicant Howmedica Osteonics Corp.

K number K001614

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KTW 2000-07-14

SAMARCO SPIDER PLATES

Applicant Biomet, Inc.

K number K001271

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KTW 1999-10-25

3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)

Applicant Synthes (Usa)

K number K992837

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KTW 1999-06-29

OMNI-FIX, HUMERAL NAIL

Applicant Turnkey Intergration USA, Inc.

K number K991405

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KTW 1999-04-01

OMNI-FIX, NAIL SYSTEM

Applicant Turnkey Intergration USA, Inc.

K number K990307

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KTW 1998-09-14

CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)

Applicant Wrightmedicaltechnologyinc

K number K982390

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KTW 1997-06-05

TRAUMA-FIX EXTERNAL FIXATOR

Applicant Trend Medical, Inc.

K number K971272

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KTW 1995-11-24

SYNTHES CANNULATED ANGLE BLADE PLATE

Applicant Synthes (Usa)

K number K954289

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KTW 1994-04-05

MALLEOLAR SCREW

Applicant Onyx Medical Corp.

K number K931686

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KTW 1993-06-01

TORUS EXTERNAL FIXATION SYSTEM

Applicant Zimmer, Inc.

K number K925635

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KTW 1992-11-24

TRUE/FLEX METATARSAL RODS

Applicant Applied Osteo Systems, Inc.

K number K924657

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KTW 1991-11-29

ANGLED BLADE PLATE

Applicant Synthes (Usa)

K number K914546

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KTW 1990-12-11

HANSEN-STREET TYPE INTRAMEDULLARY NAIL

Applicant O'Tec Corp.

K number K905348

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KTW 1989-11-03

LEVTECH SMALL BONE PLATE

Applicant Buckman Co., Inc.

K number K893928

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KTW 1987-03-09

WARSAW ORTHOPEDIC I BONE PLATE

Applicant Warsaw Orthopedic, Inc.

K number K870727

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KTW 1986-09-02

ACROMED ADS BONE NAIL

Applicant Buckman Co., Inc.

K number K862552

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KTW 1986-07-25

EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM

Applicant Orthospec, Inc.

K number K862279

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KTW 1985-05-29

LERE NAIL & PLATE COMBIN. ONE PIECE FORGED

Applicant Medicalex

K number K851349

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KTW 1984-10-01

BONE SCREWS

Applicant Mecron Medical Products, Inc.

K number K843554

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KTW 1984-10-01

BONE PLATES

Applicant Mecron Medical Products, Inc.

K number K843553

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KTW 1982-06-03

ORTHOPEDIC FIXATION DEVICES

Applicant Howmedica Corp.

K number K821566

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KTW 1982-01-29

HIP PIN

Applicant The Deca Co.

K number K813340

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KTW 1979-12-06

SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES

Applicant Synthes (Usa)

K number K792291

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KTW 1978-12-20

COMPRESSION HIP SCREW SYSTEM

Applicant Howmedica Corp.

K number K781762

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