Product code LXT
- Device name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230067 | Para-Fix External Fixation System | New Paradigm Biomedical | 2023-09-22 |
| K131636 | POLARUS CONNECT | Acumed, LLC | 2013-10-10 |
| K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | Biomet | 2013-10-09 |
| K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | Medos International SARL | 2011-10-31 |
| 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 |
| K073135 | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | Synthes (Usa) | 2008-01-29 |
| K063832 | SYNTHES (USA) ELBOW HINGE FIXATOR | Synthes (Usa) | 2007-03-07 |
| K060864 | MULTIDIRECTIONAL THREADED PEG | Hand Innovations, LLC | 2006-04-28 |
| K060403 | PTA (PROGRESSIVE TIBIAL ALIGNMENT) | Meridian Medical | 2006-03-28 |
| K060290 | SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2006-02-27 |
| K052754 | WRIST FUSION PLATE | Dvo Extremity Solutions, LLC | 2005-10-27 |
| K051728 | MODIFICATION TO SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2005-07-20 |
| K051306 | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2005-06-17 |
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | Hand Innovations, Inc. | 2005-04-26 |
| K050631 | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION | Synthes (Usa) | 2005-04-11 |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | A.M. Surgical, Inc. | 2004-10-07 |
| K042059 | SHOULDER FIXATION SYSTEM | Hand Innovations, Inc. | 2004-09-30 |
| K033805 | SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES | Synthes (Usa) | 2004-02-20 |
| K033145 | HOFFMANN II PELVIC CLAMP | Howmedica Osteonics Corp. | 2003-11-05 |
| K032705 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | 2003-10-01 |
| K032169 | CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) | Cyberorthology, Inc. | 2003-09-22 |
| K031973 | SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE | Synthes (Usa) | 2003-09-05 |
| K031428 | SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE | Synthes (Usa) | 2003-08-08 |
| K031959 | STRYKER PLATING SYSTEM PERIARTICULAR PLATES | Howmedica Osteonics Corp. | 2003-07-25 |
| K030390 | SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE | Synthes (Usa) | 2003-04-01 |
| K022651 | HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT | Howmedica Osteonics Corp. | 2002-10-17 |
| K020905 | NBX - NON-BRIDGING EXTERNAL FIXATOR | Biomet Orthopedics, Inc. | 2002-04-15 |
| K013739 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | 2001-12-13 |
| K013772 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics | 2001-12-03 |
| K011948 | HOFFMAN II HYBRID RING CLAMP | Howmedica Osteonics Corp. | 2001-07-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800089416684 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416677 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416660 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416653 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416585 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416592 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416608 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416615 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416622 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416639 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 08800089416646 | INLET System Bone Screw | Jeil Medical Corporation | 2021-11-18 |
| 10381780049586 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780065203 | Integra® Total Wrist Fusion System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780049609 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780049647 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780049692 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780049715 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780049739 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780049814 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780065197 | Integra® Total Wrist Fusion System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780049562 | SURFIX | NEWDEAL | 2017-10-09 |
| 10381780049524 | SURFIX | NEWDEAL | 2017-10-09 |
| 07613327094978 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327092653 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327091526 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327089158 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327086010 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327079128 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 08426750820064 | SMALL Y PLATE- 4 HOLES | Biomet Orthopedics, LLC | 2015-10-24 |
| 10381780064350 | Integra® Total Wrist Fusion System | INTEGRA LIFESCIENCES CORPORATION | 2015-08-15 |