STANDARD SCREW DRIVER
FDA 510(k) clearance K872387 · decided 1987-07-16
Clearance details
- K-number
- K872387
- Device name
- STANDARD SCREW DRIVER
- Applicant
- Med-Tool, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-19
- Decision date
- 1987-07-16
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- LRZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, 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 |
|---|---|---|
| MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (K896589) | Optik | 1989-12-27 |
| 1.1 SCREWDRIVERS (K872490) | Micro-Aire Surgical Instruments, Inc. | 1987-07-23 |
Recalls involving this device
No recalls on record reference this clearance.