BONE CUTTING INSTRUMENTS & ACCESSORIES
FDA 510(k) clearance K874961 · decided 1987-12-30
Clearance details
- K-number
- K874961
- Device name
- BONE CUTTING INSTRUMENTS & ACCESSORIES
- Applicant
- Solway, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-02
- Decision date
- 1987-12-30
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GDR
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hollywood, FL, 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 |
|---|---|---|
| 27-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATT (K851787) | Artiberia | 1985-06-20 |
Recalls involving this device
No recalls on record reference this clearance.