Bone Bolt System
FDA 510(k) clearance K230867 · decided 2023-06-26
Clearance details
- K-number
- K230867
- Device name
- Bone Bolt System
- Applicant
- University of Utah, Department of Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2023-03-29
- Decision date
- 2023-06-26
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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| CoAptix S System (K252699) | University of Utah, Department of Orthopaedics | 2026-04-10 |
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Recalls involving this device
No recalls on record reference this clearance.