SCHULTZ METACARPAL COMPONENT DRIVER
FDA 510(k) clearance K870848 · decided 1987-03-13
Clearance details
- K-number
- K870848
- Device name
- SCHULTZ METACARPAL COMPONENT DRIVER
- Applicant
- Warsaw Orthopedic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-03
- Decision date
- 1987-03-13
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- HWR
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, 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 |
|---|---|---|
| KNEE PROSTHESIS DRIVER (K915776) | Kim-Med, Inc. | 1992-06-11 |
| ACROMED ADS BONE NAIL DRIVER (K875054) | Buckman Co., Inc. | 1988-01-28 |
| SCHULTZ PHALANGEAL COMPONENT DRIVER (K870847) | Warsaw Orthopedic, Inc. | 1987-03-13 |
Recalls involving this device
No recalls on record reference this clearance.