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 11, 2002 | K023267 | T2 SUPRACONDYLAR NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Nov 14, 2002 | K023437 | FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL Disco-O-Tech Medical Technologies, Ltd., IL | HSB |
| Sep 23, 2002 | K022632 | SIGN IM NAIL Surgical Implant Generation Network (Sign) | HSB |
| Aug 26, 2002 | K022481 | S2 TIBIAL NAIL Howmedica Osteonics Corp. | HSB |
| Aug 26, 2002 | K021786 | TITANIUM ANKLE ARTHRODESIS NAIL Biomet, Inc. | HSB |
| Aug 22, 2002 | K022461 | S2 FEMORAL NAIL Howmedica Osteonics | HSB |
| Jul 25, 2002 | K022225 | VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM Vector Medical, Inc. | HSB |
| Jun 26, 2002 | K021744 | T2 FEMORAL NAIL Howmedica Osteonics Corp. | HSB |
| Jun 20, 2002 | K021008 | ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL Advanced Orthopaedic Solutions, Inc. | HSB |
| May 24, 2002 | K020962 | G4 SLEEVED NAIL Biomet Manufacturing, Inc. | HSB |
| May 23, 2002 | K021324 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) Disco-O-Tech Medical Technologies, Ltd., IL | HSB |
| May 16, 2002 | K020562 | APEX INTRAMEDULLARY NAIL SYSTEM Magly Orthopedics, LLC | HSB |
| May 6, 2002 | K020384 | T2 ARTHRODESIS NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Apr 25, 2002 | K021027 | S2 TIBIAL NAIL Howmedica Osteonics Corp. | HSB |
| Apr 25, 2002 | K021026 | S2 FEMORAL NAIL Howmedica Osteonics Corp. | HSB |
| Apr 4, 2002 | K020773 | LONG LENGTH GAMMA NAIL Howmedica Osteonics Corp. | HSB |
| Mar 29, 2002 | K020677 | GAMMA 3 LAG SCREW Howmedica Osteonics Corp. | HSB |
| Feb 25, 2002 | K013923 | TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER Biomet Orthopedics, Inc. | HSB |
| Jan 25, 2002 | K014220 | T2 FEMORAL NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Dec 27, 2001 | K013563 | LONG TROCHANTERIC NAIL SYSTEM DePuy Orthopaedics, Inc. | HSB |
| Dec 20, 2001 | K013132 | SIGN IM NAIL Surgical Implant Generation Network (Sign) | HSB |
| Dec 19, 2001 | K013616 | POLARUS CAP SCREW Acu Med, Inc. | HSB |
| Dec 19, 2001 | K013449 | MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM Disc-O-Tech Medical Technologies, Ltd., IL | HSB |
| Dec 17, 2001 | K013430 | ACE BIO WIN TIBIAL NAILING SYSTEM DePuy Orthopaedics, Inc. | HSB |
| Nov 16, 2001 | K013468 | LONG LENGTH DYAX NAIL Howmedica Osteonics Corp. | HSB |
| Nov 14, 2001 | K013524 | TROCHANTERIC DYAX NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Oct 4, 2001 | K012967 | MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM Disco-O-Tech Medical Technologies, Ltd., IL | HSB |
| Sep 24, 2001 | K012190 | AOS MODULAR FEMORAL NAIL Advanced Orthopaedic Solutions, Inc. | HSB |
| Sep 12, 2001 | K011857 | SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM Synthes (Usa) | HSB |
| Aug 1, 2001 | K012158 | MODIFICATION TO: LONG LENGTH GAMMA NAIL Howmedica Osteonics Corp. | HSB |
| Jul 11, 2001 | K011129 | SIGN IM NAIL Sign, Inc. | HSB |
| Jun 19, 2001 | K010988 | FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM Disc-O-Tech Medical Technologies, Ltd. | HSB |
| Jun 19, 2001 | K010901 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B Disc-O-Tech Medical Technologies, Ltd. | HSB |
| Jun 15, 2001 | K011622 | OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS Howmedica Osteonics Corp. | HSB |
| Jun 12, 2001 | K011529 | T2 HUMERAL NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Jun 12, 2001 | K010780 | TROCHANTERIC NAIL DePuy Orthopaedics, Inc. | HSB |
| May 2, 2001 | K010322 | ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) Orthodyne, Inc. | HSB |
| Apr 17, 2001 | K010149 | WUJIN #3 FEMORAL NAIL Biopro, Inc. | HSB |
| Apr 6, 2001 | K010801 | T2 FEMORAL NAIL Howmedica Osteonics Corp. | HSB |
| Dec 15, 2000 | K003797 | ACE AIM TTC FUSION NAIL DePuy Orthopaedics, Inc. | HSB |
| Dec 15, 2000 | K003018 | TITAN TIBIAL NAIL Howmedica Osteonics Corp. | HSB |
| Dec 5, 2000 | K002783 | FIXION INTERLOCKING NAIL (FIXION IL NAIL) Disco-O-Tech Medical Technologies, Ltd. | HSB |
| Oct 23, 2000 | K002278 | BROOKER FEMORAL NAILS Biomet Orthopedics, Inc. | HSB |
| Oct 4, 2000 | K002057 | BROOKER TIBIA NAILS Biomet Orthopedics, Inc. | HSB |
| Aug 29, 2000 | K001938 | VECTOR TARGETING SYSTEM Vector Medical, Inc. | HSB |
| Mar 10, 2000 | K992856 | MAGELLAN HUMERAL INTRAMEDULLARY NAIL Orthomatrix, Inc. | HSB |
| Mar 10, 2000 | K992850 | MAGELLAN TIBIAL INTRAMEDULLARY NAIL Orthomatrix, Inc. | HSB |
| Dec 20, 1999 | K993956 | TITANIUM PEDIATRIC FEMORAL NAIL Biomet, Inc. | HSB |
| Nov 19, 1999 | K993603 | WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW Howmedica Osteonics Corp. | HSB |
| Nov 16, 1999 | K993670 | MODIFIED LONG LENGTH GAMMA NAIL Howmedica Osteonics Corp. | HSB |
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