FDA 510(k) Applications for Medical Device Product Code "KTW"
(Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K160409 | ADVANCED ORTHOPAEDIC SOLUTIONS, INC | AOS Anterolateral Proximal Humeral Plate | 03/15/2016 |
| K080590 | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. | AOS PROXIMAL HUMERAL PLATE | 05/06/2008 |
| K171606 | Advanced Orthopaedic Solutions, Inc. (AOS) | AOS Anterolateral Proximal Humeral Plate | 06/22/2017 |
| K012645 | ALLIANCE MEDICAL CORP. | REPROCESSED EBI EXTERNAL FIXATION DEVICES | 06/24/2002 |
| K012634 | ALLIANCE MEDICAL, INC. | REPROCESSED EXTERNAL FIXATION DEVICE | 06/24/2002 |
| K001271 | BIOMET, INC. | SAMARCO SPIDER PLATES | 07/14/2000 |
| K001614 | HOWMEDICA OSTEONICS CORP. | STRYKER TRAUMA PELVIC SET | 08/04/2000 |
| K023360 | JEIL MEDICAL CORPORATION | LEFORTE SYSTEM BONE PLATE | 10/25/2002 |
| K122541 | ORTHOFIX SRL | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | 09/20/2012 |
| K062920 | ORTHOFIX SRL | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | 11/13/2006 |
| K182285 | Paonan Biotech Co., Ltd. | PK High Tibial Osteotomy Correction System | 06/20/2019 |
| K170693 | Paragon 28, Inc. | Phantom Small Bone Intramedullary Nail System | 06/19/2017 |
| K992837 | SYNTHES (USA) | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) | 10/25/1999 |
| K010321 | SYNTHES (USA) | MODULAR FOOT SYSTEM - 2.7 MM MODULE | 05/02/2001 |
| K080109 | SYNTHES (USA) | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM | 03/20/2008 |
| K011815 | SYNTHES (USA) | SYNTHES LCP PROXIMAL HUMERUS PLATES | 09/06/2001 |
| K011458 | SYNTHES (USA) | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM | 08/02/2001 |
| K971272 | TREND MEDICAL, INC. | TRAUMA-FIX EXTERNAL FIXATOR | 06/05/1997 |
| K991405 | TURNKEY INTERGRATION USA, INC. | OMNI-FIX, HUMERAL NAIL | 06/29/1999 |
| K990307 | TURNKEY INTERGRATION USA, INC. | OMNI-FIX, NAIL SYSTEM | 04/01/1999 |
| K982390 | WRIGHT MEDICAL TECHNOLOGY, INC. | CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) | 09/14/1998 |
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