Panels › Orthopedic › Product code HSB · Class 2
Rod, Fixation, Intramedullary And Accessories
Regulation 888.3020
20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
Top companies in HSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 295 |
| DePuy Orthopaedics, Inc. | 9 | 116 |
| Zimmer GmbH | 23 | 50 |
| Stryker | 12 | 37 |
| Howmedica Osteonics | 39 | 0 |
| OrthoPediatrics Corp. | 7 | 31 |
| Ebi, L.P. | 1 | 31 |
| Advanced Orthopaedic Solutions, Inc. | 15 | 12 |
| NuVasive Specialized Orthopedics | 18 | 9 |
| Synthes (Usa) | 23 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2010 | K101939 | OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM Merete Medical GmbH | HSB |
| Oct 1, 2010 | K101622 | ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS Zimmer, Inc. | HSB |
| Sep 28, 2010 | K100112 | SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) Sonoma Orthopedic Products, Inc. | HSB |
| Jul 12, 2010 | K100925 | ASCENSION ANKLE FUSION NAIL SYSTEM Ascension Orthopedics, Inc. | HSB |
| Jun 29, 2010 | K092720 | WRIST ARTHRODESIS NAIL SYSTEM Skeletal Dynamics, LLC | HSB |
| Jun 23, 2010 | K093707 | DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 U&I Corp., KR | HSB |
| Jun 21, 2010 | K100497 | QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) N.M.B. Medical Applications, Ltd., IL | HSB |
| Jun 17, 2010 | K101438 | T2 GREATER TROCHANTER NAIL Howmedica Osteonics Corp. | HSB |
| May 11, 2010 | K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DePuy Orthopaedics, Inc. | HSB |
| Apr 26, 2010 | K092748 | SURESHOT TAN NAILS AND ACCESSORIES Smith & Nephew, Inc. | HSB |
| Apr 20, 2010 | K100312 | DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM Dgimed Ortho, Inc. | HSB |
| Jan 21, 2010 | K091425 | QUANTUM M COMPOSITE NAILING SYSTEM N.M.B. Medical Applications, Ltd. | HSB |
| Jan 20, 2010 | K092110 | WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) Sonoma Orthopedic Products, Inc. | HSB |
| Dec 2, 2009 | K092771 | DYNA LOCKING IM NAIL U&I Corp., KR | HSB |
| Nov 13, 2009 | K093089 | MAGNUM NAIL Robert Reid, Inc. | HSB |
| Nov 5, 2009 | K091309 | REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX Dgimed Ortho, Inc. | HSB |
| Oct 28, 2009 | K091566 | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Zimmer GmbH | HSB |
| Sep 25, 2009 | K092646 | SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW Synthes (Usa) | HSB |
| Aug 17, 2009 | K091976 | BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL Biomet Trauma | HSB |
| Jul 29, 2009 | K091788 | PANTA NAIL (DIA. 10MM), PANTA NAIL XL Newdeal Sas | HSB |
| Jul 14, 2009 | K090857 | VALOR ANKLE FUSION NAIL SYSTEM Wrightmedicaltechnologyinc | HSB |
| Jun 30, 2009 | K090596 | ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM Zimmer, Inc. | HSB |
| Jun 17, 2009 | K090241 | SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) Synthes (Usa) | HSB |
| May 14, 2009 | K083648 | GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL Efratgo, Ltd. HI Tech Bio-Surgical | HSB |
| Mar 26, 2009 | K090478 | AOS PROXIMAL HUMERAL NAIL Advanced Orthopaedic Solutions, Inc. | HSB |
| Mar 11, 2009 | K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM OrthoPediatrics Corp. | HSB |
| Feb 19, 2009 | K083497 | ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS Zimmer, Inc. | HSB |
| Feb 9, 2009 | K083458 | INTRAMEDULLARY FIXATION ROD (IFS) Novalign Orthopaedics, Inc. | HSB |
| Feb 1, 2009 | K090091 | OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM Mylad Orthopedic Solutions, LLC | HSB |
| Jan 27, 2009 | K082754 | AEQUALIS HUMERAL NAIL SYSTEM Tornier | HSB |
| Jan 13, 2009 | K081230 | TRAUSON INTRAMEDULLARY NAIL Trauson (Jiangsu) Medical Instrument Co., Ltd., CN | HSB |
| Dec 18, 2008 | K083437 | MODIFICATION TO T2 RECON NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Dec 11, 2008 | K082770 | ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL Zimmer, Inc. | HSB |
| Oct 10, 2008 | K082018 | T2 FLEXIBLE NAIL Howmedica Osteonics Corp. | HSB |
| Oct 10, 2008 | K081832 | ENSPLINTCMX CLAVICLE PIN Sonoma Orthopedic Products, Inc. | HSB |
| Aug 11, 2008 | K082148 | SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION Synthes (Usa) | HSB |
| Jul 18, 2008 | K081452 | SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM Synthes (Usa) | HSB |
| Jul 9, 2008 | K081356 | OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM Mylad Orthopedic Solutions, LLC | HSB |
| Jun 27, 2008 | K081243 | BIOMET PHOENIX ANKLE NAIL SYSTEM Biomet Trauma | HSB |
| Jun 10, 2008 | K081152 | T2 FEMORAL NAIL Howmedica Osteonics Corp. | HSB |
| Feb 29, 2008 | K073402 | SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM Synthes (Usa) | HSB |
| Feb 7, 2008 | K070761 | SANATMETAL NAILS AND PINS Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. | HSB |
| Dec 17, 2007 | K071679 | METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS Disc-O-Tech Medical Technologies, Ltd., IL | HSB |
| Oct 12, 2007 | K070955 | ACID ETCHED LAG SCREWS Biomet Orthopedics, Inc. | HSB |
| Sep 20, 2007 | K072161 | BIOMET FEMORAL LOCKING NAIL SYSTEM Biomet Manufacturing Corp | HSB |
| Aug 9, 2007 | K071944 | ACUMED SMALL BONE LOCKING SYSTEM II Acumed, LLC | HSB |
| Jun 14, 2007 | K070444 | AOS TIBIAL NAIL Advanced Orthopaedic Solutions, Inc. | HSB |
| May 2, 2007 | K070843 | SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM Synthes (Usa) | HSB |
| Mar 1, 2007 | K070294 | SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES Synthes (Usa) | HSB |
| Feb 27, 2007 | K063570 | BIOMET TIBIAL LOCKING NAIL SYSTEM Biomet Manufacturing Corp | HSB |
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