Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

FDA product code LXT · 57 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: 1986-12-18 – 2023-09-22

LXT 2023-09-22

Para-Fix External Fixation System

Applicant New Paradigm Biomedical

K number K230067

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LXT 2013-10-10

POLARUS CONNECT

Applicant Acumed, LLC

K number K131636

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LXT 2013-10-09

DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW

Applicant Biomet

K number K132704

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LXT 2011-10-31

DISTAL VOLAR RADIUS PLATING SYSTEMS

Applicant Medos International SARL

K number K112345

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LXT 2009-03-11

STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S

Applicant DePuy Orthopaedics, Inc.

K number K090374

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LXT 2008-01-29

SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS

Applicant Synthes (Usa)

K number K073135

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LXT 2007-03-07

SYNTHES (USA) ELBOW HINGE FIXATOR

Applicant Synthes (Usa)

K number K063832

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LXT 2006-04-28

MULTIDIRECTIONAL THREADED PEG

Applicant Hand Innovations, LLC

K number K060864

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LXT 2006-03-28

PTA (PROGRESSIVE TIBIAL ALIGNMENT)

Applicant Meridian Medical

K number K060403

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LXT 2006-02-27

SHOULDER FIXATION SYSTEM

Applicant Hand Innovations, LLC

K number K060290

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LXT 2005-10-27

WRIST FUSION PLATE

Applicant Dvo Extremity Solutions, LLC

K number K052754

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LXT 2005-07-20

MODIFICATION TO SHOULDER FIXATION SYSTEM

Applicant Hand Innovations, LLC

K number K051728

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LXT 2005-06-17

HOFFMANN II MRI EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K051306

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LXT 2005-04-26

DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM

Applicant Hand Innovations, Inc.

K number K050932

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LXT 2005-04-11

SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION

Applicant Synthes (Usa)

K number K050631

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LXT 2004-10-07

A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM

Applicant A.M. Surgical, Inc.

K number K042458

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LXT 2004-09-30

SHOULDER FIXATION SYSTEM

Applicant Hand Innovations, Inc.

K number K042059

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LXT 2004-02-20

SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES

Applicant Synthes (Usa)

K number K033805

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LXT 2003-11-05

HOFFMANN II PELVIC CLAMP

Applicant Howmedica Osteonics Corp.

K number K033145

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LXT 2003-10-01

DISTAL RADIUS FRACTURE REPAIR SYSTEM

Applicant Hand Innovations, Inc.

K number K032705

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LXT 2003-09-22

CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)

Applicant Cyberorthology, Inc.

K number K032169

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LXT 2003-09-05

SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE

Applicant Synthes (Usa)

K number K031973

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LXT 2003-08-08

SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE

Applicant Synthes (Usa)

K number K031428

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LXT 2003-07-25

STRYKER PLATING SYSTEM PERIARTICULAR PLATES

Applicant Howmedica Osteonics Corp.

K number K031959

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LXT 2003-04-01

SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE

Applicant Synthes (Usa)

K number K030390

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LXT 2002-10-17

HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT

Applicant Howmedica Osteonics Corp.

K number K022651

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LXT 2002-04-15

NBX - NON-BRIDGING EXTERNAL FIXATOR

Applicant Biomet Orthopedics, Inc.

K number K020905

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LXT 2001-12-13

MODIFICATION TO EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K013739

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LXT 2001-12-03

MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics

K number K013772

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LXT 2001-07-13

HOFFMAN II HYBRID RING CLAMP

Applicant Howmedica Osteonics Corp.

K number K011948

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LXT 2000-12-29

BIOMET EXTERNAL WRIST PLATE

Applicant Biomet, Inc.

K number K003240

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LXT 2000-12-18

DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K002923

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LXT 2000-12-15

HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING

Applicant Howmedica Osteonics Corp.

K number K003211

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LXT 2000-12-15

TRANSFX ANGLED RODS

Applicant Immedica, Inc.

K number K003205

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LXT 2000-08-31

RADIOLUCENT COLLES FRACTURE KIT

Applicant Biomet, Inc.

K number K001760

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LXT 2000-08-17

SYNTHES SCALLOPED DISTAL TIBIA PLATE

Applicant Synthes (Usa)

K number K001793

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LXT 2000-06-16

SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS

Applicant Synthes (Usa)

K number K000972

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LXT 2000-06-15

TRANS FX ADJUSTABLE PIN TO BAR CLAMP

Applicant Immedica, Inc.

K number K001084

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LXT 2000-05-23

HOFFMANN II EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K000957

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LXT 2000-04-14

SYNTHES (USA) WRIST FUSION PLATES (WFP)

Applicant Synthes (Usa)

K number K000558

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LXT 1999-08-12

ULTIMAX HAIG II NAIL SYSTEM

Applicant Encore Orthopedics, Inc.

K number K991889

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LXT 1999-07-22

TRANSFX MULTI PIN CLAMP

Applicant Immedica, Inc.

K number K991723

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LXT 1999-06-11

SYNTHES LOCKING CALCANEAL PLATES

Applicant Synthes (Usa)

K number K991407

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LXT 1999-05-17

TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION

Applicant Immedica, Inc.

K number K990848

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LXT 1999-03-04

TRANSFX EXTERNAL FIXATION SYSTEM

Applicant Immedica, Inc.

K number K984357

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LXT 1998-05-22

DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI

Applicant Depuy Ace Medical Co.

K number K974245

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LXT 1996-11-13

GUIDE WIRES FOR CANNULATED SCREWS

Applicant Orthopaedic Biosystems, Ltd.

K number K963432

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LXT 1996-11-12

SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)

Applicant Synthes (Usa)

K number K963618

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LXT 1996-10-23

EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM

Applicant Biodynamic Technologies, Inc.

K number K962846

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LXT 1996-05-16

BERLIN EXTERNAL FIXATOR

Applicant Encore Orthopedics, Inc.

K number K954053

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LXT 1996-04-04

TITANIUM UNIVERSAL CLAMP

Applicant Synthes (Usa)

K number K960269

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LXT 1996-01-31

ACE-DUPONT COMPOSITE RINGS

Applicant Ace Medical Co.

K number K955388

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LXT 1995-10-31

HEX-FIX FIELD FIXATOR

Applicant Smith & Nephew Richards, Inc.

K number K953397

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LXT 1995-05-22

SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR

Applicant Synthes (Usa)

K number K950384

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LXT 1994-10-03

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR

Applicant Applied Osteo Systems, Inc.

K number K941048

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LXT 1988-05-20

ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY

Applicant Harrington Arthritis Research Center

K number K874377

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LXT 1986-12-18

MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM

Applicant Howmedica Corp.

K number K864403

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