Product code HTR
- Device name
- Rasp
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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 |
|---|---|---|---|
| K870329 | ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 | Biodynamic Technologies, Inc. | 1987-02-13 |
| K870333 | BIODYNAMICS SMALL JOINT BRUSH #1203 | Biodynamic Technologies, Inc. | 1987-02-13 |
| K870349 | BIODYNAMICS FEMORAL CANAL BRUSH #1201 | Biodynamic Technologies, Inc. | 1987-02-13 |
| K813093 | RICHARDS ACETABULAR BRUSH | Richard'S Medical Equip., Inc. | 1981-11-20 |
| K812506 | THE ARTHROFILE | Dyonics, Inc. | 1981-09-24 |
| K780771 | MICRO RASPS | Amsco Co. | 1978-05-16 |
| K771016 | INTERMEDULLARY BRUSH | Howmedica Corp. | 1978-01-12 |
| K771745 | RASPS FOR SCRAPING BONE | Depuy, Inc. | 1977-09-28 |
| K760109 | PROSTHESIS, TOTAL HIP-RASP | Orthopedic Equipment Co., Inc. | 1976-07-20 |
Related GUDID Devices#
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|---|---|---|---|
| 00190776435110 | Millennium | Avalign Technologies, Inc. | 2026-10-15 |
| 00190776435103 | Millennium | Avalign Technologies, Inc. | 2026-10-15 |
| 00888912103572 | DJO SURGICAL | Encore Medical, L.P. | 2026-10-09 |
| 00888912103589 | DJO SURGICAL | Encore Medical, L.P. | 2026-10-09 |
| 00840311258635 | C-Plus PEEK IBF System | Xtant Medical Holdings, Inc. | 2026-08-26 |
| 04054462904105 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904099 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904037 | evonos | evonos GmbH & Co. KG | 2026-08-21 |
| 04054462904082 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462904075 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462904068 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462904051 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462904020 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462904013 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462904006 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 00643169060739 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00840096400038 | Viant Medical, LLC | VIANT MEDICAL | 2020-09-29 |
| 00840096400021 | Viant Medical, LLC | VIANT MEDICAL | 2020-09-29 |
| 00840096400014 | Viant Medical, LLC | VIANT MEDICAL | 2020-09-29 |
| 00840096400007 | Viant Medical, LLC | VIANT MEDICAL | 2020-09-29 |
| 00191083026664 | C-Plus PEEK IBF System | Xtant Medical Holdings, Inc. | 2020-09-25 |
| 10381780192831 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780192824 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780192817 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10886982000606 | NA | Synthes GmbH | 2017-02-20 |
| 10886982000613 | NA | Synthes GmbH | 2017-02-20 |
| 10886982000620 | NA | Synthes GmbH | 2017-02-20 |
| 10886982000637 | NA | Synthes GmbH | 2017-02-20 |
| 10886982000590 | NA | Synthes GmbH | 2017-02-20 |
| 10886982000583 | NA | Synthes GmbH | 2017-02-20 |