K252699
- 510(k) number
- K252699
- Device name
- CoAptix S System
- Applicant
- University of Utah, Department of Orthopaedics UT · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2026-04-10
- Date received
- 2025-08-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K252699.pdf
Official FDA record: K252699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.