ClearanceBrief
Panels › Orthopedic › Product code LXT · Class 2

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

Regulation 888.3030

0510(k)s in 12 months (57 all time)
0recalls in 12 months (14 all time)
14recalls that name a 510(k)
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Top companies in LXT

Company510(k)sRecalls
Synthes (Usa)140
Howmedica Osteonics90
Zimmer Inc.07
Hand Innovations, Inc.60
Immedica, Inc.51
Biomet32
Encore Orthopedics, Inc.20
Zimmer Biomet, Inc.02
A.M. Surgical, Inc.10
Ace Medical Co.10
Decided510(k)Device and applicantCode
Sep 22, 2023K230067Para-Fix External Fixation System
New Paradigm Biomedical
LXT
Oct 10, 2013K131636POLARUS CONNECT
Acumed, LLC
LXT
Oct 9, 2013K132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
Biomet
LXT
Oct 31, 2011K112345DISTAL VOLAR RADIUS PLATING SYSTEMS
Medos International SARL
LXT
Mar 11, 2009K090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
DePuy Orthopaedics, Inc.
LXT
Jan 29, 2008K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
Synthes (Usa)
LXT
Mar 7, 2007K063832SYNTHES (USA) ELBOW HINGE FIXATOR
Synthes (Usa)
LXT
Apr 28, 2006K060864MULTIDIRECTIONAL THREADED PEG
Hand Innovations, LLC
LXT
Mar 28, 2006K060403PTA (PROGRESSIVE TIBIAL ALIGNMENT)
Meridian Medical
LXT
Feb 27, 2006K060290SHOULDER FIXATION SYSTEM
Hand Innovations, LLC
LXT
Oct 27, 2005K052754WRIST FUSION PLATE
Dvo Extremity Solutions, LLC
LXT
Jul 20, 2005K051728MODIFICATION TO SHOULDER FIXATION SYSTEM
Hand Innovations, LLC
LXT
Jun 17, 2005K051306HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
LXT
Apr 26, 2005K050932DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
Hand Innovations, Inc.
LXT
Apr 11, 2005K050631SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
Synthes (Usa)
LXT
Oct 7, 2004K042458A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
A.M. Surgical, Inc.
LXT
Sep 30, 2004K042059SHOULDER FIXATION SYSTEM
Hand Innovations, Inc.
LXT
Feb 20, 2004K033805SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
Synthes (Usa)
LXT
Nov 5, 2003K033145HOFFMANN II PELVIC CLAMP
Howmedica Osteonics Corp.
LXT
Oct 1, 2003K032705DISTAL RADIUS FRACTURE REPAIR SYSTEM
Hand Innovations, Inc.
LXT
Sep 22, 2003K032169CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
Cyberorthology, Inc.
LXT
Sep 5, 2003K031973SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
Synthes (Usa)
LXT
Aug 8, 2003K031428SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
Synthes (Usa)
LXT
Jul 25, 2003K031959STRYKER PLATING SYSTEM PERIARTICULAR PLATES
Howmedica Osteonics Corp.
LXT
Apr 1, 2003K030390SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
Synthes (Usa)
LXT
Oct 17, 2002K022651HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
Howmedica Osteonics Corp.
LXT
Apr 15, 2002K020905NBX - NON-BRIDGING EXTERNAL FIXATOR
Biomet Orthopedics, Inc.
LXT
Dec 13, 2001K013739MODIFICATION TO EBI XFIX DFS SYSTEM
Ebi, L.P.
LXT
Dec 3, 2001K013772MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
Howmedica Osteonics
LXT
Jul 13, 2001K011948HOFFMAN II HYBRID RING CLAMP
Howmedica Osteonics Corp.
LXT
Dec 29, 2000K003240BIOMET EXTERNAL WRIST PLATE
Biomet, Inc.
LXT
Dec 18, 2000K002923DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
LXT
Dec 15, 2000K003211HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
Howmedica Osteonics Corp.
LXT
Dec 15, 2000K003205TRANSFX ANGLED RODS
Immedica, Inc.
LXT
Aug 31, 2000K001760RADIOLUCENT COLLES FRACTURE KIT
Biomet, Inc.
LXT
Aug 17, 2000K001793SYNTHES SCALLOPED DISTAL TIBIA PLATE
Synthes (Usa)
LXT
Jun 16, 2000K000972SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
Synthes (Usa)
LXT
Jun 15, 2000K001084TRANS FX ADJUSTABLE PIN TO BAR CLAMP
Immedica, Inc.
LXT
May 23, 2000K000957HOFFMANN II EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
LXT
Apr 14, 2000K000558SYNTHES (USA) WRIST FUSION PLATES (WFP)
Synthes (Usa)
LXT
Aug 12, 1999K991889ULTIMAX HAIG II NAIL SYSTEM
Encore Orthopedics, Inc.
LXT
Jul 22, 1999K991723TRANSFX MULTI PIN CLAMP
Immedica, Inc.
LXT
Jun 11, 1999K991407SYNTHES LOCKING CALCANEAL PLATES
Synthes (Usa)
LXT
May 17, 1999K990848TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
Immedica, Inc.
LXT
Mar 4, 1999K984357TRANSFX EXTERNAL FIXATION SYSTEM
Immedica, Inc.
LXT
May 22, 1998K974245DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
Depuy Ace Medical Co.
LXT
Nov 13, 1996K963432GUIDE WIRES FOR CANNULATED SCREWS
Orthopaedic Biosystems, Ltd.
LXT
Nov 12, 1996K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
Synthes (Usa)
LXT
Oct 23, 1996K962846EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
Biodynamic Technologies, Inc.
LXT
May 16, 1996K954053BERLIN EXTERNAL FIXATOR
Encore Orthopedics, Inc.
LXT

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