TriMed Wrist Fixation System 3
FDA 510(k) clearance K222637 · decided 2022-12-21
Clearance details
- K-number
- K222637
- Device name
- TriMed Wrist Fixation System 3
- Applicant
- TriMed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-31
- Decision date
- 2022-12-21
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Santa Clarita, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEA recall (Z-0932-2024) | TriMed Inc. | 2024-01-31 |