Panels › Orthopedic › Product code HWT · Class 1
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Regulation 888.4800
0510(k)s in 12 months (10 all time)
0recalls in 12 months (85 all time)
21recalls that name a 510(k)
Top companies in HWT
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Inc. | 0 | 46 |
| Waldemar Link GmbH & Co. KG (Corp. Hq.) | 0 | 21 |
| Biomet, Inc. | 1 | 4 |
| Stryker Howmedica Osteonics Corp. | 0 | 4 |
| DePuy Orthopaedics, Inc. | 0 | 3 |
| Aesculap Implant Systems LLC | 0 | 2 |
| Depuy, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| Biomet Microfixation, LLC | 0 | 1 |
| Encore Medical, Lp | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 1998 | K974406 | ORTHOPLAN Ortho-Graphics, Inc. | HWT |
| Jan 17, 1997 | K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 Integrated Surgical Systems, Inc. | HWT |
| Jul 23, 1990 | K894228 | KRONNER SPHERICAL CUTTERS Kronner Medical | HWT |
| May 27, 1987 | K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA Warsaw Orthopedic, Inc. | HWT |
| May 1, 1987 | K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM Orthopedic Systems, Inc. | HWT |
| Mar 1, 1983 | K830360 | 3M OSTEOTOMY GUIDE 3M Company | HWT |
| May 21, 1981 | K811205 | MOLDED POLYSULFONE TRIAL PROSTHESIS Shannon Group | HWT |
| Jul 17, 1978 | K781091 | KNEE INSTRUMENTATION, CONDYLAR Biomet, Inc. | HWT |
| Oct 6, 1977 | K771710 | WORRELL PATELLA TEMPLATE Depuy, Inc. | HWT |
| Oct 6, 1977 | K771709 | WORRELL TRIAL PATELLA Depuy, Inc. | HWT |
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