FDA 510(k) Applications for Medical Device Product Code "LXT"
(Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K042458 | A.M. SURGICAL, INC. | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | 10/07/2004 |
| K955388 | ACE MEDICAL CO. | ACE-DUPONT COMPOSITE RINGS | 01/31/1996 |
| K131636 | ACUMED LLC | POLARUS CONNECT | 10/10/2013 |
| K962846 | BIODYNAMIC TECHNOLOGIES, INC. | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | 10/23/1996 |
| K132704 | BIOMET | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | 10/09/2013 |
| K020905 | BIOMET ORTHOPEDICS, INC. | NBX - NON-BRIDGING EXTERNAL FIXATOR | 04/15/2002 |
| K003240 | BIOMET, INC. | BIOMET EXTERNAL WRIST PLATE | 12/29/2000 |
| K001760 | BIOMET, INC. | RADIOLUCENT COLLES FRACTURE KIT | 08/31/2000 |
| K032169 | CYBERORTHOLOGY, INC. | CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) | 09/22/2003 |
| K974245 | DEPUY ACE MEDICAL CO. | DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI | 05/22/1998 |
| K090374 | DEPUY ORTHOPAEDICS, INC. | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | 03/11/2009 |
| K052754 | DVO EXTREMITY SOLUTIONS, LLC | WRIST FUSION PLATE | 10/27/2005 |
| K013739 | EBI, L.P. | MODIFICATION TO EBI XFIX DFS SYSTEM | 12/13/2001 |
| K954053 | ENCORE ORTHOPEDICS, INC. | BERLIN EXTERNAL FIXATOR | 05/16/1996 |
| K991889 | ENCORE ORTHOPEDICS, INC. | ULTIMAX HAIG II NAIL SYSTEM | 08/12/1999 |
| K032705 | HAND INNOVATIONS, INC. | DISTAL RADIUS FRACTURE REPAIR SYSTEM | 10/01/2003 |
| K050932 | HAND INNOVATIONS, INC. | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | 04/26/2005 |
| K042059 | HAND INNOVATIONS, INC. | SHOULDER FIXATION SYSTEM | 09/30/2004 |
| K051728 | HAND INNOVATIONS, LLC. | MODIFICATION TO SHOULDER FIXATION SYSTEM | 07/20/2005 |
| K060864 | HAND INNOVATIONS, LLC. | MULTIDIRECTIONAL THREADED PEG | 04/28/2006 |
| K060290 | HAND INNOVATIONS, LLC. | SHOULDER FIXATION SYSTEM | 02/27/2006 |
| K013772 | HOWMEDICA OSTEONICS | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | 12/03/2001 |
| K002923 | HOWMEDICA OSTEONICS CORP. | DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM | 12/18/2000 |
| K011948 | HOWMEDICA OSTEONICS CORP. | HOFFMAN II HYBRID RING CLAMP | 07/13/2001 |
| K022651 | HOWMEDICA OSTEONICS CORP. | HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT | 10/17/2002 |
| K003211 | HOWMEDICA OSTEONICS CORP. | HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING | 12/15/2000 |
| K000957 | HOWMEDICA OSTEONICS CORP. | HOFFMANN II EXTERNAL FIXATION SYSTEM | 05/23/2000 |
| K051306 | HOWMEDICA OSTEONICS CORP. | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | 06/17/2005 |
| K033145 | HOWMEDICA OSTEONICS CORP. | HOFFMANN II PELVIC CLAMP | 11/05/2003 |
| K031959 | HOWMEDICA OSTEONICS CORP. | STRYKER PLATING SYSTEM PERIARTICULAR PLATES | 07/25/2003 |
| K001084 | IMMEDICA, INC. | TRANS FX ADJUSTABLE PIN TO BAR CLAMP | 06/15/2000 |
| K003205 | IMMEDICA, INC. | TRANSFX ANGLED RODS | 12/15/2000 |
| K984357 | IMMEDICA, INC. | TRANSFX EXTERNAL FIXATION SYSTEM | 03/04/1999 |
| K990848 | IMMEDICA, INC. | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION | 05/17/1999 |
| K991723 | IMMEDICA, INC. | TRANSFX MULTI PIN CLAMP | 07/22/1999 |
| K112345 | MEDOS INTERNATIONAL SARL | DISTAL VOLAR RADIUS PLATING SYSTEMS | 10/31/2011 |
| K060403 | MERIDIAN MEDICAL | PTA (PROGRESSIVE TIBIAL ALIGNMENT) | 03/28/2006 |
| K230067 | New Paradigm Biomedical | Para-Fix External Fixation System | 09/22/2023 |
| K963432 | ORTHOPAEDIC BIOSYSTEMS, LTD. | GUIDE WIRES FOR CANNULATED SCREWS | 11/13/1996 |
| K033805 | SYNTHES (USA) | SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES | 02/20/2004 |
| K063832 | SYNTHES (USA) | SYNTHES (USA) ELBOW HINGE FIXATOR | 03/07/2007 |
| K073135 | SYNTHES (USA) | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | 01/29/2008 |
| K031428 | SYNTHES (USA) | SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE | 08/08/2003 |
| K050631 | SYNTHES (USA) | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION | 04/11/2005 |
| K000972 | SYNTHES (USA) | SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS | 06/16/2000 |
| K000558 | SYNTHES (USA) | SYNTHES (USA) WRIST FUSION PLATES (WFP) | 04/14/2000 |
| K031973 | SYNTHES (USA) | SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE | 09/05/2003 |
| K030390 | SYNTHES (USA) | SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE | 04/01/2003 |
| K991407 | SYNTHES (USA) | SYNTHES LOCKING CALCANEAL PLATES | 06/11/1999 |
| K001793 | SYNTHES (USA) | SYNTHES SCALLOPED DISTAL TIBIA PLATE | 08/17/2000 |
| K963618 | SYNTHES (USA) | SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) | 11/12/1996 |
| K960269 | SYNTHES (USA) | TITANIUM UNIVERSAL CLAMP | 04/04/1996 |
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