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 |
|---|---|---|---|
| 10885862663207 | N/A | Exactech, Inc. | 2026-05-28 |
| 08059386748701 | Orthopaedic Surgical Instruments | CITIEFFE SRL | 2026-05-27 |
| 08800017270500 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270487 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270470 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270463 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270449 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270425 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270401 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270388 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270364 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270340 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270333 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270326 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270319 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270302 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270296 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270289 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270272 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 08800017270265 | BENCOX | Corentec Co., Ltd | 2026-04-02 |
| 07640187918410 | TRIGEN MAX ENTRY REAMER 12.5 MM, HALL-JACOBS | MPS Micro Precision Systems AG | 2026-02-24 |
| G079C5090000070 | Golden Isles Pedicle Screw System | Intelivation, LLC | 2022-09-23 |
| 07640187910469 | LINK Instrument | WALDEMAR LINK GmbH & Co. KG | 2019-08-05 |
| 07640187910445 | LINK Instrument | WALDEMAR LINK GmbH & Co. KG | 2019-08-05 |
| 07640187910421 | LINK Instrument | WALDEMAR LINK GmbH & Co. KG | 2019-08-05 |
| 07640187910407 | LINK Instrument | WALDEMAR LINK GmbH & Co. KG | 2019-08-05 |
| 08033390101790 | H-MAX S Femoral Stem | LIMACORPORATE SPA | 2018-09-21 |
| 08033390090261 | H-MAX S Femoral Stem | LIMACORPORATE SPA | 2018-09-21 |
| 08033390090254 | H-MAX S Femoral Stem | LIMACORPORATE SPA | 2018-09-21 |
| 08033390079235 | H-MAX S Femoral Stem | LIMACORPORATE SPA | 2018-09-21 |