MANUAL RONGEUR
FDA 510(k) clearance K874954 · decided 1987-12-30
Clearance details
- K-number
- K874954
- Device name
- MANUAL RONGEUR
- 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
- HTX
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| FRONT RADIUS CUTTER (K841620) | Plastafil, Inc. | 1984-09-20 |
| BACK RADIUS CUTTER (K841621) | Plastafil, Inc. | 1984-09-20 |
| ORTHOPEDIC FORCEPS (K780397) | Orthopedic Equipment Co., Inc. | 1978-03-22 |
| SURGICAL INSTRUMENTS, ORTHOPEDIC (K760325) | Depuy, Inc. | 1976-08-03 |
Recalls involving this device
No recalls on record reference this clearance.