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 |
|---|---|---|---|
| Sep 22, 1999 | K992350 | PYLON INTRAMEDULLAARY NAIL SYSTEM Alphatec Mfg., Inc. | HSB |
| Sep 3, 1999 | K992063 | OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY Howmedica Osteonics Corp. | HSB |
| Aug 6, 1999 | K991790 | ULTIMAX ANKLE FUSION ROD SYSTEM Encore Orthopedics, Inc. | HSB |
| Jun 2, 1999 | K990717 | FIXION INTRAMEDULLARY NAILING SYSTEM Disco-O-Tech Medical Technologies, Ltd. | HSB |
| Apr 1, 1999 | K990322 | PERRY HUMERAL NAIL Pioneer Surgical Technology | HSB |
| Mar 31, 1999 | K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. | HSB |
| Mar 15, 1999 | K990152 | OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER Howmedica Osteonics Corp. | HSB |
| Mar 5, 1999 | K984602 | SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM Syntec Scientific Corp., TW | HSB |
| Mar 1, 1999 | K984543 | SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 Syntec Scientific Corp., TW | HSB |
| Feb 1, 1999 | K990120 | MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE Depuy Ace Medical Co. | HSB |
| Feb 1, 1999 | K984305 | ZETA MULTIZONE LOCKING NAIL SYSTEM Howmedica, Inc. | HSB |
| Dec 16, 1998 | K984353 | OSTEO 9MM IC TIBIAL NAIL Osteonics Corp. | HSB |
| Dec 4, 1998 | K983641 | HOLLAND FEMORAL NAIL SYSTEM Biomet, Inc. | HSB |
| Nov 20, 1998 | K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM Howmedica Corp. | HSB |
| Nov 18, 1998 | K983358 | G/K SFN AND STN LOCKING NAILS Howmedica, Inc. | HSB |
| Oct 27, 1998 | K983339 | OSTEO DYNATROC PROXIMAL FEMORAL NAIL Osteonics Corp. | HSB |
| Oct 21, 1998 | K982953 | TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES Biomet, Inc. | HSB |
| Oct 21, 1998 | K982873 | ZETA MULTIZONE SCN LOCKING NAIL Howmedica Corp. | HSB |
| Sep 14, 1998 | K982602 | RETROGRADE ROD SYSTEM Howmedica Corp. | HSB |
| Sep 14, 1998 | K982601 | OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL Osteonics Corp. | HSB |
| Jun 22, 1998 | K981309 | OSTEO I-C HUMERAL NAIL SYSTEM Osteonics Corp. | HSB |
| Jun 22, 1998 | K981261 | HOWMEDICA SCN NAIL Howmedica Corp. | HSB |
| Jun 1, 1998 | K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. | HSB |
| May 18, 1998 | K980609 | SEGMENTAL DEFECT REPLACEMENT SYSTEM Metagen, LLC | HSB |
| Apr 3, 1998 | K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. | HSB |
| Mar 13, 1998 | K974720 | HOWMEDICA(R) FULLY THREADED SCREWS Howmedica, Inc. | HSB |
| Mar 10, 1998 | K974781 | DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL Depuy, Inc. | HSB |
| Dec 19, 1997 | K973944 | ORTHOFIX FEMORAL NAILING SYTEM Orthofix Srl | HSB |
| Oct 9, 1997 | K972813 | GAMMA LOCKING NAIL SYSTEM Howmedica Corp. | HSB |
| Oct 6, 1997 | K972811 | HOWMEDICA FULLY THREADED SCREWS Howmedica Corp. | HSB |
| Oct 3, 1997 | K971056 | MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION Wrightmedicaltechnologyinc | HSB |
| Sep 19, 1997 | K972692 | MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL Zimmer, Inc. | HSB |
| Aug 26, 1997 | K972183 | DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL Ace Medical Co. | HSB |
| Aug 12, 1997 | K972108 | ALTA INTRAMEDULLARY ROD SYSTEM Howmedica Corp. | HSB |
| Aug 11, 1997 | K964444 | QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM Rdh Medical | HSB |
| Jul 18, 1997 | K971816 | ATLAS FRACTURE PROXIMAL HUMERAL NAIL Biomet, Inc. | HSB |
| Jun 5, 1997 | K971135 | MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM Wrightmedicaltechnologyinc | HSB |
| May 22, 1997 | K970280 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES Ferguson Medical | HSB |
| May 22, 1997 | K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES Ferguson Medical | HSB |
| Apr 21, 1997 | K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. | HSB |
| Mar 21, 1997 | K970202 | DEPUY ACE AIM TITANIUM TIBIAL NAIL Depuy Ace Medical Co. | HSB |
| Mar 13, 1997 | K961360 | TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM Encore Orthopedics, Inc. | HSB |
| Feb 28, 1997 | K965098 | INTRAMEDULLARY NAIL SYSTEM Zimmer, Inc. | HSB |
| Dec 27, 1996 | K964163 | TRIMAX NAIL SYSTEM Smith & Nephew Richards, Inc. | HSB |
| Dec 5, 1996 | K964243 | HUMERUS WIRES Compagnie Financiere & Medicale (Cf&M), FR | HSB |
| Oct 28, 1996 | K963026 | TBD Acu Med, Inc. | HSB |
| Oct 1, 1996 | K963077 | TBD Acu Med, Inc. | HSB |
| Sep 25, 1996 | K962561 | SUPRACONDYLAR INTRAMEDULLARY NAIL Zimmer, Inc. | HSB |
| Sep 25, 1996 | K962552 | EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. | HSB |
| Aug 28, 1996 | K962553 | EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. | HSB |
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