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 |