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Component, Traction, Invasive

FDA product code JEC · 84 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3040
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-17 – 2021-04-23

JEC 2021-04-23

SteriTrak

Applicant Arbutus Medical, Inc.

K number K203605

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JEC 2020-03-02

Anjon Bremer Halo System

Applicant Anjon Holdings, LLC

K number K193256

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JEC 2019-10-10

DigiFix Sterile Kit

Applicant Virak Orthopedics, LLC

K number K192465

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JEC 2018-10-22

PIP Fix

Applicant Hand Biomechanics Lab, Inc.

K number K181192

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JEC 2018-03-19

Anjon Bremer Halo System

Applicant Anjon Holdings, LLC

K number K171863

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JEC 2016-12-28

Medline ReNewal Reprocessed Stryker External Fixation Devices

Applicant Surgical Instrument Service and Savings, Inc.

K number K163028

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JEC 2011-01-14

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX

Applicant Stryker Corp.

K number K102885

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JEC 2009-04-07

LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X

Applicant Sintea Biotech, Inc.

K number K082679

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JEC 2008-01-09

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE

Applicant Hand Biomechanics Lab, Inc.

K number K072432

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JEC 2007-08-24

SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP

Applicant Synthes (Usa)

K number K071476

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JEC 2004-08-25

KLSA MARTIN HAND DISTRACTOR

Applicant KLS-Martin L.P.

K number K042066

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JEC 2003-10-09

FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM

Applicant Meridan Medical

K number K032427

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JEC 2003-07-24

HOFFMANN II COMPACT BALTIMORE COUPLING

Applicant Howmedica Osteonics Corp.

K number K031941

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JEC 2003-06-10

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS

Applicant Hand Biomechanics Lab, Inc.

K number K030519

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JEC 2002-09-23

ORTHOGUARD AB ANTIMICROBIAL SLEEVE

Applicant Smith & Nephew, Inc.

K number K022676

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JEC 2002-08-06

SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X

Applicant Sintea Biotech, Inc.

K number K022065

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JEC 2002-07-11

AMC ANTIMICROBIAL PIN/WIRE SLEEVE

Applicant Smith & Nephew, Inc.

K number K012193

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JEC 2001-12-05

AUTOGENESIS AUTOMATOR, MODEL M1000

Applicant Autogenesis, Inc.

K number K013818

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JEC 2001-01-11

HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST

Applicant Howmedica Osteonics Corp.

K number K003848

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JEC 1999-12-15

BREMER HALO SYSTEM TITANIUM SKULL PIN

Applicant Depuyacromed

K number K993099

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JEC 1999-05-21

CENTRAFIX EXTERNAL FIXATOR

Applicant Owandar Medical, Ltd.

K number K991732

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JEC 1999-02-12

AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147

Applicant Hand Biomechanics Lab, Inc.

K number K984442

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JEC 1998-05-20

AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000

Applicant Autogenesis, Inc.

K number K981423

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JEC 1997-07-17

HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM

Applicant Howmedica Corp.

K number K971755

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JEC 1997-02-19

STABLELOC II EXTERNAL FIXATOR

Applicant Acu Med, Inc.

K number K965029

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JEC 1996-11-06

MONOTUBE CARBON TUBE

Applicant Howmedica Corp.

K number K963614

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JEC 1996-08-01

HOFFMANN II CARBON CONNECTING ROD

Applicant Howmedica, Inc.

K number K961916

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JEC 1996-05-28

MONOTUBE TUBE TO RING CLAMP

Applicant Howmedica Corp.

K number K961618

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JEC 1996-05-08

TITANIUM TUBE TO TUBE CLAMP

Applicant Synthes (Usa)

K number K960782

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JEC 1996-01-24

EZ FIX

Applicant Biodynamic Technologies, Inc.

K number K954838

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JEC 1996-01-11

MONOTUBE TUBE-TO-TUBE CLAMP

Applicant Howmedica Corp.

K number K954667

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JEC 1995-10-05

EXTERNAL FIXATOR

Applicant Acu Med, Inc.

K number K952330

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JEC 1995-09-08

HOFFMANN II EXTERNAL FIXATION SYSTEM

Applicant Howmedica Corp.

K number K952730

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JEC 1995-04-04

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM

Applicant Orthofix Srl

K number K944092

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JEC 1995-01-27

EXTERNAL FIXATOR

Applicant Acu Med, Inc.

K number K943857

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JEC 1994-06-16

ACE PELVIC STABILIZER

Applicant Ace Medical Co.

K number K933968

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JEC 1994-03-10

PELVIC C-CLAMP

Applicant Synthes (Usa)

K number K922796

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JEC 1994-02-22

HOWMEDICA MONOTUBE T-CONNECTOR

Applicant Howmedica, Inc.

K number K936124

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JEC 1994-02-22

ACE UNILATERAL FIXATOR II

Applicant Ace Orthopedic Manufacturing Co.

K number K936045

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JEC 1994-02-22

HOWMEDICA MONO-TUBE SINGLE PIN CLAMP

Applicant Howmedica Corp.

K number K934698

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JEC 1994-02-22

TEXAS SCOTTISH RITE EASY/LOCK FIXATOR

Applicant Applied Osteo Systems, Inc.

K number K931578

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JEC 1993-08-06

SYSTEM III HALO RING

Applicant Jerome Medical

K number K930153

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JEC 1992-10-06

HALO ESPRIT

Applicant Itm Corp.

K number K920117

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JEC 1992-04-09

OSTEO EX-FI-RE

Applicant Osteo AG

K number K920149

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JEC 1992-03-16

BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN

Applicant Bremer Medical, Inc.

K number K915800

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JEC 1991-11-21

ACE OPEN-BACK HALO RING

Applicant Ace Medical Co.

K number K914858

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JEC 1990-09-14

CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO

Applicant Alphatec Mfg., Inc.

K number K894959

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JEC 1990-09-06

OLIVE K-WIRES

Applicant Danek Medical, Inc.

K number K903105

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JEC 1990-06-21

ACE WIRE TENSION CLAMP

Applicant Buckman Co., Inc.

K number K901984

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JEC 1990-04-30

SYNTHES EXTERNAL FIXATION BONE CLIP

Applicant Synthes (Usa)

K number K894098

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JEC 1990-01-11

ACE WIRE TENSION CLAMP

Applicant Buckman Co., Inc.

K number K894982

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JEC 1989-08-11

TRACER DYNAMIC AXIAL FIXATION

Applicant Tracer Medical

K number K892638

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JEC 1989-02-10

AME PINSITE SHIELD(TM)

Applicant American Medical Electronics, Inc.

K number K884798

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JEC 1988-12-29

MODIFIED CHICK AMBULATORY HALO

Applicant Chick Medical Products

K number K884242

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JEC 1988-09-30

JMS CERVICAL TRACTION DEVICE/HALO DEVICE

Applicant Jerome Medical

K number K882877

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JEC 1988-07-28

KIRSCHNER SUPER-FIXATION SYSTEM

Applicant Kirschner Medical Corp.

K number K881896

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JEC 1988-06-03

LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER

Applicant Lima-Lto, Inc.

K number K881673

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JEC 1988-02-18

LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER

Applicant Lima-Lto, Inc.

K number K880282

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JEC 1987-07-10

VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS

Applicant Vitaphore Corp.

K number K872538

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JEC 1985-08-09

EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)

Applicant Howmedica Corp.

K number K852397

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JEC 1985-02-13

AGEE EXTERNAL FIXATOR

Applicant The Hand Biomechanics Research Laboratory

K number K842493

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JEC 1984-09-11

SABA-COOMBS MINI EXTERNAL FIXATOR

Applicant Zimmer, Inc.

K number K842343

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JEC 1984-05-16

RICHARDS FIXATOR SYSTEM

Applicant Richards Medical Co., Inc.

K number K841334

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JEC 1984-04-25

MODULAR CONSTRUCT FRAME EXTERNAL FIXA

Applicant Precision Medical Devices, Inc.

K number K840856

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JEC 1983-10-20

OXFORD MARK 2 EXTERNAL FIXATOR

Applicant Johnson & Johnson Professionals, Inc.

K number K833114

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JEC 1983-06-08

ORTHOFIX

Applicant Electro-Biology, Inc.

K number K831576

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JEC 1983-02-02

COLLES FRACTURE FRAME

Applicant Richard'S Medical Equip., Inc.

K number K830154

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JEC 1982-10-06

CERVICAL BRACE

Applicant Jerome Medical

K number K822780

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JEC 1981-01-09

DOUBLE BALL JOINT

Applicant Howmedica Corp.

K number K803166

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JEC 1980-12-10

ORTHOFIX AXIALEXTERNAL FIXATION SYS.

Applicant Cintor Orthopaedic Div.

K number K802814

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JEC 1980-11-19

HOFFMAN LEG LENGTHENING DEVICE

Applicant Howmedica Corp.

K number K802776

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JEC 1980-11-19

EXTENDED BALLJOINT GRIP

Applicant Howmedica Corp.

K number K802723

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JEC 1980-11-19

EXTERNAL FIXATION SYSTEM

Applicant Howmedica Corp.

K number K802722

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JEC 1980-02-11

OXFORD EXTERNAL FIXATION SYSTEM

Applicant Downs Surgical , Ltd.

K number K800184

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JEC 1979-12-19

MINI-H-FIXATION

Applicant Geny Medical, Inc.

K number K792561

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JEC 1979-08-16

ACE EXTERNAL BONE CLAMP PART #S11

Applicant Ace Orthopedic Manufacturing Co.

K number K791466

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JEC 1979-02-13

UNIVERSAL EXTERNAL FIXATION ASSEMBLY

Applicant Zimmer, Inc.

K number K790262

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JEC 1978-11-08

BAR, DISTRACTION

Applicant Ace Orthopedic Manufacturing Co.

K number K781841

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JEC 1978-11-08

EXTERNAL ARTICULATION

Applicant Ace Orthopedic Manufacturing Co.

K number K781840

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JEC 1978-11-08

BONE CLAMP, ACE EXTERNAL

Applicant Ace Orthopedic Manufacturing Co.

K number K781839

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JEC 1978-11-03

FRAME, UNIVERSAL DAY

Applicant B.G. Orthopedic Corp.

K number K781793

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JEC 1977-03-30

TIBIAL COMPRESSION FRAM FOR FRACTURES

Applicant Richard F. Kronner, M.D.

K number K770066

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JEC 1977-03-14

FRACTURE REDUCTION SYS., MODEL OR 1001

Applicant Sisan Assoc.

K number K770388

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JEC 1976-12-17

DEPUY MODIFIED SKELETAL TRACTION PIN

Applicant Depuy, Inc.

K number K761088

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