Panels › Orthopedic › Product code KTW · Class 2
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Regulation 888.3030
0510(k)s in 12 months (38 all time)
0recalls in 12 months (57 all time)
57recalls that name a 510(k)
Top companies in KTW
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes USA (HQ), Inc. | 0 | 57 |
| Synthes (Usa) | 8 | 0 |
| Advanced Orthopaedic Solutions, Inc. | 2 | 0 |
| Alliance Medical Corp. | 2 | 0 |
| Buckman Co., Inc. | 2 | 0 |
| Howmedica Corp. | 2 | 0 |
| Mecron Medical Products, Inc. | 2 | 0 |
| Orthofix Srl | 2 | 0 |
| Turnkey Intergration USA, Inc. | 2 | 0 |
| Advanced Orthopaedic Solutions, Inc. (Aos) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2019 | K182285 | PK High Tibial Osteotomy Correction System Paonan Biotech Co., Ltd., TW | KTW |
| Jun 22, 2017 | K171606 | AOS Anterolateral Proximal Humeral Plate Advanced Orthopaedic Solutions, Inc. (Aos) | KTW |
| Jun 19, 2017 | K170693 | Phantom Small Bone Intramedullary Nail System Paragon 28, Inc. | KTW |
| Mar 15, 2016 | K160409 | AOS Anterolateral Proximal Humeral Plate Advanced Orthopaedic Solutions, Inc. | KTW |
| Sep 20, 2012 | K122541 | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) Orthofix Srl | KTW |
| May 6, 2008 | K080590 | AOS PROXIMAL HUMERAL PLATE Advanced Orthopaedic Solutions, Inc. | KTW |
| Mar 20, 2008 | K080109 | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM Synthes (Usa) | KTW |
| Nov 13, 2006 | K062920 | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP Orthofix Srl | KTW |
| Oct 25, 2002 | K023360 | LEFORTE SYSTEM BONE PLATE Jeil Medical Corporation | KTW |
| Jun 24, 2002 | K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES Alliance Medical Corp. | KTW |
| Jun 24, 2002 | K012634 | REPROCESSED EXTERNAL FIXATION DEVICE Alliance Medical, Inc. | KTW |
| Sep 6, 2001 | K011815 | SYNTHES LCP PROXIMAL HUMERUS PLATES Synthes (Usa) | KTW |
| Aug 2, 2001 | K011458 | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM Synthes (Usa) | KTW |
| May 2, 2001 | K010321 | MODULAR FOOT SYSTEM - 2.7 MM MODULE Synthes (Usa) | KTW |
| Aug 4, 2000 | K001614 | STRYKER TRAUMA PELVIC SET Howmedica Osteonics Corp. | KTW |
| Jul 14, 2000 | K001271 | SAMARCO SPIDER PLATES Biomet, Inc. | KTW |
| Oct 25, 1999 | K992837 | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) Synthes (Usa) | KTW |
| Jun 29, 1999 | K991405 | OMNI-FIX, HUMERAL NAIL Turnkey Intergration USA, Inc. | KTW |
| Apr 1, 1999 | K990307 | OMNI-FIX, NAIL SYSTEM Turnkey Intergration USA, Inc. | KTW |
| Sep 14, 1998 | K982390 | CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) Wrightmedicaltechnologyinc | KTW |
| Jun 5, 1997 | K971272 | TRAUMA-FIX EXTERNAL FIXATOR Trend Medical, Inc. | KTW |
| Nov 24, 1995 | K954289 | SYNTHES CANNULATED ANGLE BLADE PLATE Synthes (Usa) | KTW |
| Apr 5, 1994 | K931686 | MALLEOLAR SCREW Onyx Medical Corp. | KTW |
| Jun 1, 1993 | K925635 | TORUS EXTERNAL FIXATION SYSTEM Zimmer, Inc. | KTW |
| Nov 24, 1992 | K924657 | TRUE/FLEX METATARSAL RODS Applied Osteo Systems, Inc. | KTW |
| Nov 29, 1991 | K914546 | ANGLED BLADE PLATE Synthes (Usa) | KTW |
| Dec 11, 1990 | K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL O'Tec Corp. | KTW |
| Nov 3, 1989 | K893928 | LEVTECH SMALL BONE PLATE Buckman Co., Inc. | KTW |
| Mar 9, 1987 | K870727 | WARSAW ORTHOPEDIC I BONE PLATE Warsaw Orthopedic, Inc. | KTW |
| Sep 2, 1986 | K862552 | ACROMED ADS BONE NAIL Buckman Co., Inc. | KTW |
| Jul 25, 1986 | K862279 | EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM Orthospec, Inc. | KTW |
| May 29, 1985 | K851349 | LERE NAIL & PLATE COMBIN. ONE PIECE FORGED Medicalex, FR | KTW |
| Oct 1, 1984 | K843554 | BONE SCREWS Mecron Medical Products, Inc. | KTW |
| Oct 1, 1984 | K843553 | BONE PLATES Mecron Medical Products, Inc. | KTW |
| Jun 3, 1982 | K821566 | ORTHOPEDIC FIXATION DEVICES Howmedica Corp. | KTW |
| Jan 29, 1982 | K813340 | HIP PIN The Deca Co. | KTW |
| Dec 6, 1979 | K792291 | SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES Synthes (Usa) | KTW |
| Dec 20, 1978 | K781762 | COMPRESSION HIP SCREW SYSTEM Howmedica Corp. | KTW |
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