RICHARDS ACETABULAR BRUSH
FDA 510(k) clearance K813093 · decided 1981-11-20
Clearance details
- K-number
- K813093
- Device name
- RICHARDS ACETABULAR BRUSH
- Applicant
- Richard'S Medical Equip., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-02
- Decision date
- 1981-11-20
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- HTR
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIODYNAMICS FEMORAL CANAL BRUSH #1201 (K870349) | Biodynamic Technologies, Inc. | 1987-02-13 |
| BIODYNAMICS SMALL JOINT BRUSH #1203 (K870333) | Biodynamic Technologies, Inc. | 1987-02-13 |
| ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (K870329) | Biodynamic Technologies, Inc. | 1987-02-13 |
| THE ARTHROFILE (K812506) | Dyonics, Inc. | 1981-09-24 |
| MICRO RASPS (K780771) | Amsco Co. | 1978-05-16 |
| INTERMEDULLARY BRUSH (K771016) | Howmedica Corp. | 1978-01-12 |
| RASPS FOR SCRAPING BONE (K771745) | Depuy, Inc. | 1977-09-28 |
| PROSTHESIS, TOTAL HIP-RASP (K760109) | Orthopedic Equipment Co., Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.