PRECISION SCREW DRIVER SET
FDA 510(k) clearance K872389 · decided 1987-07-15
Clearance details
- K-number
- K872389
- Device name
- PRECISION SCREW DRIVER SET
- Applicant
- Med-Tool, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-19
- Decision date
- 1987-07-15
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- HXX
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER (K901166) | Dalton Technology, Inc. | 1990-06-13 |
| ACROMED SCREW DRIVER (K873066) | Buckman Co., Inc. | 1987-09-02 |
| 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP (K862689) | W. L. Gore & Associates, Inc. | 1986-09-02 |
Recalls involving this device
No recalls on record reference this clearance.