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 |
|---|---|---|---|
| Dec 27, 2006 | K063225 | METAIZEAU NAILING SYSTEM Howmedica Osteonics Corp. | HSB |
| Sep 21, 2006 | K061910 | SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) Synthes (Usa) | HSB |
| Jun 16, 2006 | K051965 | OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM Merete Medical GmbH | HSB |
| Apr 13, 2006 | K060921 | S2 RECON NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Dec 12, 2005 | K053261 | ORTHOFIX TITANIUM NAILING SYSTEMS Orthofix Srl | HSB |
| Dec 2, 2005 | K053105 | SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP Synthes (Usa) | HSB |
| Sep 21, 2005 | K051678 | SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM Synthes (Usa) | HSB |
| Aug 22, 2005 | K052058 | MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie, FR | HSB |
| Jul 29, 2005 | K051590 | T2 ANKLE ARTHRODESIS NAIL Howmedica Osteonics Corp. | HSB |
| Jul 7, 2005 | K051624 | T2 RECON NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| May 27, 2005 | K050882 | NEWDEAL ANKLE NAIL New Deal, S.A. | HSB |
| Mar 14, 2005 | K050241 | AOS HUMERAL NAIL Advanced Orthopaedic Solutions, Inc. | HSB |
| Feb 16, 2005 | K050118 | EBI TROCHANTERIC NAIL SYSTEM Ebi, L.P. | HSB |
| Feb 16, 2005 | K043431 | GAMMA3 NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Feb 3, 2005 | K043200 | SIGN FIN NAIL Surgical Implant Generation Network (Sign) | HSB |
| Feb 1, 2005 | K043233 | GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL Efratgo, Ltd. HI Tech Bio-Surgical | HSB |
| Jan 31, 2005 | K043270 | SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES Zimmer GmbH | HSB |
| Dec 27, 2004 | K043404 | MODIFICATION TO T2 PROXIMAL HUMERAL NAIL Howmedica Osteonics Corp. | HSB |
| Dec 2, 2004 | K042409 | MODULAR ARTHRODESIS NAIL Biomet, Inc. | HSB |
| Nov 24, 2004 | K043052 | TRIGEN HINDFOOT FUSION NAIL Smith & Nephew, Inc. | HSB |
| Oct 8, 2004 | K042396 | T2 PROXIMAL HUMERAL NAIL Howmedica Osteonics Corp. | HSB |
| Oct 7, 2004 | K042440 | ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM Alphatec/Nexmed | HSB |
| Oct 7, 2004 | K042332 | TITANIUM TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie, FR | HSB |
| Oct 7, 2004 | K042135 | SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) Synthes (Usa) | HSB |
| Sep 8, 2004 | K042325 | TROCHANTERIC NAIL SYSTEM DePuy Orthopaedics, Inc. | HSB |
| Aug 17, 2004 | K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM Pega Medical, Inc., CA | HSB |
| May 25, 2004 | K040929 | TRIGEN ADOLESCENT TAN Smith & Nephew, Inc. | HSB |
| Apr 12, 2004 | K040336 | SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM Synthes (Usa) | HSB |
| Mar 23, 2004 | K040462 | TRIGEN TROCHANTERIC ANTEGRADE NAIL Smith & Nephew, Inc. | HSB |
| Feb 20, 2004 | K033878 | ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM Depuy Ace | HSB |
| Feb 20, 2004 | K033806 | ACE PROXIMAL HUMERAL NAIL SYSTEM Depuy Ace | HSB |
| Feb 5, 2004 | K033618 | SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM Synthes (Usa) | HSB |
| Jan 15, 2004 | K034002 | GAMMA3 NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Jan 12, 2004 | K033286 | ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM Orthopedic Designs, Inc. (Odi) | HSB |
| Dec 3, 2003 | K033510 | MODIFICATION TO TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie, FR | HSB |
| Nov 14, 2003 | K033329 | DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS Depuy, Inc. | HSB |
| Oct 22, 2003 | K032523 | T2 NAILING SYSTEM Howmedica Osteonics Corp. | HSB |
| Oct 9, 2003 | K032898 | T2 RECON NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Oct 1, 2003 | K032722 | TRIGEN STRAIGHT HUMERAL NAIL SYSTEM Smith & Nephew, Inc. | HSB |
| Sep 12, 2003 | K032588 | MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) Disco-O-Tech Medical Technologies, Ltd., IL | HSB |
| Sep 10, 2003 | K032548 | IP-XS COMPRESSION NAIL SYSTEM Plus Orthopedics | HSB |
| Aug 29, 2003 | K032579 | S2 NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Aug 12, 2003 | K032367 | ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL Zimmer, Inc. | HSB |
| Aug 8, 2003 | K032244 | GAMMA 3 NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Aug 8, 2003 | K032097 | DEPUY ACE VERSANAIL TIBIAL NAIL DePuy Orthopaedics, Inc. | HSB |
| Jul 17, 2003 | K031438 | ACUMED SMALL BONE LOCKING ROD SYSTEM II Acumed, LLC | HSB |
| May 28, 2003 | K031219 | MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) Orthofix, Inc. | HSB |
| Feb 6, 2003 | K020885 | FASSIRE-DUVAL TELESCOPIC IM SYSTEM Pega Medical, Inc., CA | HSB |
| Dec 24, 2002 | K023241 | TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie | HSB |
| Dec 18, 2002 | K023115 | ACE VERSANAIL DePuy Orthopaedics, Inc. | HSB |
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