FDA Product Code
FDA Product Code HTO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.4540
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | Synthes (USA) Products, LLC | 2011-08-10 | Traditional | PDF ↗ |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | Synthes (Usa) | 2005-03-16 | Traditional | PDF ↗ |
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2001-12-21 | Special | PDF ↗ |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2000-06-12 | Traditional | PDF ↗ |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Zimmer, Inc. | 1995-12-28 | Traditional | PDF ↗ |
| K903248 | COMBINATION REAMER | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K885100 | MCCONNELL REAMER GUIDE | Mcconnell Orthopedic | 1989-01-13 | Traditional | PDF ↗ |
| K870845 | WARSAW ORTHOPEDIC POINTED REAMER | Warsaw Orthopedic, Inc. | 1987-03-11 | Traditional | PDF ↗ |
| K862933 | ABC-1000 SMALL JOINT REAMERS | Instrumentation Industries, Inc. | 1986-08-18 | Traditional | PDF ↗ |
| K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS | Hirata Sangyo Co. USA, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K811081 | MEDULLARY CANAL SCRAPERS | The Anspach Effort, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K790996 | C.C.F. FEMORAL DEBRIDEMENT PROBE | Depuy, Inc. | 1979-06-27 | Traditional | PDF ↗ |
| K790307 | FLEXIBLE REAMER, GUIDE WIRE SYSTEM | 3M Company | 1979-02-22 | Traditional | PDF ↗ |
| K770203 | HAND REAMERS | Depuy, Inc. | 1977-02-08 | Traditional | PDF ↗ |
Product code HTO · Class I · Orthopedic. Data: openFDA.