WIRE
FDA 510(k) clearance K841628 · decided 1984-07-23
Clearance details
- K-number
- K841628
- Device name
- WIRE
- Applicant
- Plastafil, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-19
- Decision date
- 1984-07-23
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- HXN
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| OSTEO-CABLE SLEEVE (K024022) | Biomet, Inc. | 2003-01-23 |
Recalls involving this device
No recalls on record reference this clearance.