Product code HTO
- Device name
- Reamer
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | Synthes (USA) Products, LLC | 2011-08-10 |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | Synthes (Usa) | 2005-03-16 |
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2001-12-21 |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2000-06-12 |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Zimmer, Inc. | 1995-12-28 |
| K903248 | COMBINATION REAMER | Onyx Medical Corp. | 1990-07-30 |
| K885100 | MCCONNELL REAMER GUIDE | Mcconnell Orthopedic | 1989-01-13 |
| K870845 | WARSAW ORTHOPEDIC POINTED REAMER | Warsaw Orthopedic, Inc. | 1987-03-11 |
| K862933 | ABC-1000 SMALL JOINT REAMERS | Instrumentation Industries, Inc. | 1986-08-18 |
| K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS | Hirata Sangyo Co. USA, Inc. | 1983-10-14 |
| K811081 | MEDULLARY CANAL SCRAPERS | The Anspach Effort, Inc. | 1981-04-29 |
| K790996 | C.C.F. FEMORAL DEBRIDEMENT PROBE | Depuy, Inc. | 1979-06-27 |
| K790307 | FLEXIBLE REAMER, GUIDE WIRE SYSTEM | 3M Company | 1979-02-22 |
| K770203 | HAND REAMERS | Depuy, Inc. | 1977-02-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840096408393 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408539 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408522 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408515 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408508 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408492 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408485 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408478 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408461 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408454 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408447 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408430 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408423 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408416 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408409 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408249 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408386 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408379 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408362 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408355 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408348 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408331 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408324 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408317 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408300 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408294 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408287 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408270 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408263 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |
| 00840096408256 | Viant Medical, LLC | VIANT MEDICAL | 2020-08-25 |