TORQUEDRIVER WRENCH
FDA 510(k) clearance K870053 · decided 1987-03-11
Clearance details
- K-number
- K870053
- Device name
- TORQUEDRIVER WRENCH
- Applicant
- Jerome Medical
- Decision
- Substantially Equivalent
- Date received
- 1987-01-07
- Decision date
- 1987-03-11
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HXC
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mt Laurel, NJ, 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 |
|---|---|---|
| Intellitorq (K180092) | Gauthier Biomedical, Inc. | 2018-03-08 |
| ADJUSTABLE WRENCHES (K874359) | Med-Tool, Inc. | 1987-11-23 |
| COMBINATION WRENCHES (K874358) | Med-Tool, Inc. | 1987-11-23 |
| SPINAL WRENCH (K813067) | Twin City Surgical, Inc. | 1981-11-24 |
| WRENCH (K791073) | Truth, Inc. | 1979-06-20 |
Recalls involving this device
No recalls on record reference this clearance.