KLEIN WIRE TIGHTENER/BIONIC WIRE
FDA 510(k) clearance K833726 · decided 1983-12-22
Clearance details
- K-number
- K833726
- Device name
- KLEIN WIRE TIGHTENER/BIONIC WIRE
- Applicant
- Bionic Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-24
- Decision date
- 1983-12-22
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- HXS
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Walker, MI, 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 |
|---|---|---|
| FLAT WRENCH (K781451) | Orthopedic Equipment Co., Inc. | 1978-09-27 |
Recalls involving this device
No recalls on record reference this clearance.