Panels › Orthopedic › Product code HTO · Class 1
Reamer
Regulation 888.4540
0510(k)s in 12 months (14 all time)
0recalls in 12 months (83 all time)
20recalls that name a 510(k)
Top companies in HTO
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (USA) Products, LLC | 1 | 35 |
| Biomet, Inc. | 0 | 25 |
| Apex Surgical, LLC | 0 | 6 |
| Stryker Howmedica Osteonics Corp. | 0 | 4 |
| Synthes (Usa) | 3 | 1 |
| Depuy, Inc. | 2 | 0 |
| Zimmer, Inc. | 1 | 1 |
| 3M Company | 1 | 0 |
| The Anspach Effort, Inc. | 1 | 0 |
| Arthrex, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2011 | K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) Synthes (USA) Products, LLC | HTO |
| Mar 16, 2005 | K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS Synthes (Usa) | HTO |
| Dec 21, 2001 | K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM Synthes (Usa) | HTO |
| Jun 12, 2000 | K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM Synthes (Usa) | HTO |
| Dec 28, 1995 | K954915 | FLEXIBLE INTRAMEDULLARY REAMER Zimmer, Inc. | HTO |
| Jul 30, 1990 | K903248 | COMBINATION REAMER Onyx Medical Corp. | HTO |
| Jan 13, 1989 | K885100 | MCCONNELL REAMER GUIDE Mcconnell Orthopedic | HTO |
| Mar 11, 1987 | K870845 | WARSAW ORTHOPEDIC POINTED REAMER Warsaw Orthopedic, Inc. | HTO |
| Aug 18, 1986 | K862933 | ABC-1000 SMALL JOINT REAMERS Instrumentation Industries, Inc. | HTO |
| Oct 14, 1983 | K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS Hirata Sangyo Co. USA, Inc. | HTO |
| Apr 29, 1981 | K811081 | MEDULLARY CANAL SCRAPERS The Anspach Effort, Inc. | HTO |
| Jun 27, 1979 | K790996 | C.C.F. FEMORAL DEBRIDEMENT PROBE Depuy, Inc. | HTO |
| Feb 22, 1979 | K790307 | FLEXIBLE REAMER, GUIDE WIRE SYSTEM 3M Company | HTO |
| Feb 8, 1977 | K770203 | HAND REAMERS Depuy, Inc. | HTO |
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