HTO — Reamer Class I
FDA Device Classification
Classification Details
- Product Code
- HTO
- Device Class
- Class I
- Regulation Number
- 888.4540
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K111437 | synthes (usa) products | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | August 10, 2011 |
| K042899 | synthes (usa) | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | March 16, 2005 |
| K013527 | synthes (usa) | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | December 21, 2001 |
| K993335 | synthes (usa) | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | June 12, 2000 |
| K954915 | zimmer | FLEXIBLE INTRAMEDULLARY REAMER | December 28, 1995 |
| K903248 | onyx medical | COMBINATION REAMER | July 30, 1990 |
| K885100 | mcconnell orthopedic | MCCONNELL REAMER GUIDE | January 13, 1989 |
| K870845 | warsaw orthopedic | WARSAW ORTHOPEDIC POINTED REAMER | March 11, 1987 |
| K862933 | instrumentation industries | ABC-1000 SMALL JOINT REAMERS | August 18, 1986 |
| K832686 | hirata sangyo co. usa | MULTIPLE MANUAL SURGICAL INSTRUMENTS | October 14, 1983 |
| K811081 | anspach effort | MEDULLARY CANAL SCRAPERS | April 29, 1981 |
| K790996 | depuy | C.C.F. FEMORAL DEBRIDEMENT PROBE | June 27, 1979 |
| K790307 | 3m | FLEXIBLE REAMER, GUIDE WIRE SYSTEM | February 22, 1979 |
| K770203 | depuy | HAND REAMERS | February 8, 1977 |