RAYLOR(TM) MALLET
FDA 510(k) clearance K864422 · decided 1986-11-24
Clearance details
- K-number
- K864422
- Device name
- RAYLOR(TM) MALLET
- Applicant
- Cedar Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-10
- Decision date
- 1986-11-24
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HWA
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Minnetonka, MN, 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 |
|---|---|---|
| MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (K933527) | Mira, Inc. | 1994-01-25 |
| MALLET (K841627) | Plastafil, Inc. | 1984-08-27 |
| CEMENT CHISELS (K770205) | Depuy, Inc. | 1977-02-08 |
Recalls involving this device
No recalls on record reference this clearance.