Anatomical Plating System (various)
FDA 510(k) clearance K232652 · decided 2023-12-13
Clearance details
- K-number
- K232652
- Device name
- Anatomical Plating System (various)
- Applicant
- Tyber Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-08-31
- Decision date
- 2023-12-13
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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