FDA Product Code
FDA Product Code LXT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230067 | Para-Fix External Fixation System | New Paradigm Biomedical | 2023-09-22 | Traditional | PDF ↗ |
| K131636 | POLARUS CONNECT | Acumed, LLC | 2013-10-10 | Traditional | PDF ↗ |
| K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | Biomet | 2013-10-09 | Traditional | PDF ↗ |
| K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | Medos International SARL | 2011-10-31 | Traditional | PDF ↗ |
| K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | DePuy Orthopaedics, Inc. | 2009-03-11 | Special | PDF ↗ |
| K073135 | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | Synthes (Usa) | 2008-01-29 | Traditional | PDF ↗ |
| K063832 | SYNTHES (USA) ELBOW HINGE FIXATOR | Synthes (Usa) | 2007-03-07 | Traditional | PDF ↗ |
| K060864 | MULTIDIRECTIONAL THREADED PEG | Hand Innovations, LLC | 2006-04-28 | Special | PDF ↗ |
| K060403 | PTA (PROGRESSIVE TIBIAL ALIGNMENT) | Meridian Medical | 2006-03-28 | Traditional | PDF ↗ |
| K060290 | SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2006-02-27 | Special | PDF ↗ |
| K052754 | WRIST FUSION PLATE | Dvo Extremity Solutions, LLC | 2005-10-27 | Traditional | PDF ↗ |
| K051728 | MODIFICATION TO SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2005-07-20 | Special | PDF ↗ |
| K051306 | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2005-06-17 | Special | PDF ↗ |
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | Hand Innovations, Inc. | 2005-04-26 | Special | PDF ↗ |
| K050631 | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION | Synthes (Usa) | 2005-04-11 | Traditional | PDF ↗ |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | A.M. Surgical, Inc. | 2004-10-07 | Traditional | PDF ↗ |
| K042059 | SHOULDER FIXATION SYSTEM | Hand Innovations, Inc. | 2004-09-30 | Traditional | PDF ↗ |
| K033805 | SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES | Synthes (Usa) | 2004-02-20 | Traditional | PDF ↗ |
| K033145 | HOFFMANN II PELVIC CLAMP | Howmedica Osteonics Corp. | 2003-11-05 | Traditional | PDF ↗ |
| K032705 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | 2003-10-01 | Special | PDF ↗ |
| K032169 | CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) | Cyberorthology, Inc. | 2003-09-22 | Traditional | PDF ↗ |
| K031973 | SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE | Synthes (Usa) | 2003-09-05 | Traditional | PDF ↗ |
| K031428 | SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE | Synthes (Usa) | 2003-08-08 | Traditional | PDF ↗ |
| K031959 | STRYKER PLATING SYSTEM PERIARTICULAR PLATES | Howmedica Osteonics Corp. | 2003-07-25 | Special | PDF ↗ |
| K030390 | SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE | Synthes (Usa) | 2003-04-01 | Traditional | PDF ↗ |
| K022651 | HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT | Howmedica Osteonics Corp. | 2002-10-17 | Traditional | PDF ↗ |
| K020905 | NBX - NON-BRIDGING EXTERNAL FIXATOR | Biomet Orthopedics, Inc. | 2002-04-15 | Special | PDF ↗ |
| K013739 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | 2001-12-13 | Special | PDF ↗ |
| K013772 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics | 2001-12-03 | Special | PDF ↗ |
| K011948 | HOFFMAN II HYBRID RING CLAMP | Howmedica Osteonics Corp. | 2001-07-13 | Special | PDF ↗ |
| K003240 | BIOMET EXTERNAL WRIST PLATE | Biomet, Inc. | 2000-12-29 | Traditional | PDF ↗ |
| K002923 | DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2000-12-18 | Traditional | PDF ↗ |
| K003205 | TRANSFX ANGLED RODS | Immedica, Inc. | 2000-12-15 | Traditional | PDF ↗ |
| K003211 | HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING | Howmedica Osteonics Corp. | 2000-12-15 | Traditional | PDF ↗ |
| K001760 | RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | 2000-08-31 | Abbreviated | PDF ↗ |
| K001793 | SYNTHES SCALLOPED DISTAL TIBIA PLATE | Synthes (Usa) | 2000-08-17 | Traditional | PDF ↗ |
| K000972 | SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS | Synthes (Usa) | 2000-06-16 | Traditional | PDF ↗ |
| K001084 | TRANS FX ADJUSTABLE PIN TO BAR CLAMP | Immedica, Inc. | 2000-06-15 | Traditional | PDF ↗ |
| K000957 | HOFFMANN II EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2000-05-23 | Traditional | PDF ↗ |
| K000558 | SYNTHES (USA) WRIST FUSION PLATES (WFP) | Synthes (Usa) | 2000-04-14 | Traditional | PDF ↗ |
| K991889 | ULTIMAX HAIG II NAIL SYSTEM | Encore Orthopedics, Inc. | 1999-08-12 | Traditional | PDF ↗ |
| K991723 | TRANSFX MULTI PIN CLAMP | Immedica, Inc. | 1999-07-22 | Traditional | PDF ↗ |
| K991407 | SYNTHES LOCKING CALCANEAL PLATES | Synthes (Usa) | 1999-06-11 | Traditional | PDF ↗ |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION | Immedica, Inc. | 1999-05-17 | Traditional | PDF ↗ |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM | Immedica, Inc. | 1999-03-04 | Traditional | PDF ↗ |
| K974245 | DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI | Depuy Ace Medical Co. | 1998-05-22 | Traditional | PDF ↗ |
| K963432 | GUIDE WIRES FOR CANNULATED SCREWS | Orthopaedic Biosystems, Ltd. | 1996-11-13 | Traditional | PDF ↗ |
| K963618 | SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) | Synthes (Usa) | 1996-11-12 | Traditional | PDF ↗ |
| K962846 | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | Biodynamic Technologies, Inc. | 1996-10-23 | Traditional | PDF ↗ |
| K954053 | BERLIN EXTERNAL FIXATOR | Encore Orthopedics, Inc. | 1996-05-16 | Traditional | PDF ↗ |
| K960269 | TITANIUM UNIVERSAL CLAMP | Synthes (Usa) | 1996-04-04 | Traditional | PDF ↗ |
| K955388 | ACE-DUPONT COMPOSITE RINGS | Ace Medical Co. | 1996-01-31 | Traditional | PDF ↗ |
| K953397 | HEX-FIX FIELD FIXATOR | Smith & Nephew Richards, Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K950384 | SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR | Synthes (Usa) | 1995-05-22 | Traditional | PDF ↗ |
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | Applied Osteo Systems, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K874377 | ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY | Harrington Arthritis Research Center | 1988-05-20 | Traditional | PDF ↗ |
| K864403 | MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM | Howmedica Corp. | 1986-12-18 | Traditional | PDF ↗ |
Product code LXT · Class II · Orthopedic. Data: openFDA.