BONE PLATE
FDA 510(k) clearance K931244 · decided 1994-02-15
Clearance details
- K-number
- K931244
- Device name
- BONE PLATE
- Applicant
- Acu Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-11
- Decision date
- 1994-02-15
- Days to decision
- 341 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beaverton, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available recall (Z-1516-2014) | Acumed LLC | 2014-04-25 |