INTERMEDULLARY BRUSH
FDA 510(k) clearance K771016 · decided 1978-01-12
Clearance details
- K-number
- K771016
- Device name
- INTERMEDULLARY BRUSH
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-06
- Decision date
- 1978-01-12
- Days to decision
- 220 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
- Mchenry, IL, 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 |
| RICHARDS ACETABULAR BRUSH (K813093) | Richard'S Medical Equip., Inc. | 1981-11-20 |
| THE ARTHROFILE (K812506) | Dyonics, Inc. | 1981-09-24 |
| MICRO RASPS (K780771) | Amsco Co. | 1978-05-16 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |