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#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08806395408917 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395409006 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408993 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408986 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408979 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408962 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408955 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408948 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408931 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 08806395408924 | Pulsar | GS Medical Co., Ltd. | 2022-11-01 |
| 00841732124684 | GENERIC Surgical Instruments | CTL Medical Corporation | 2019-10-18 |
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