FDA applicant
University of Utah, Department of Orthopaedics
FDA records 2 decisions for University of Utah, Department of Orthopaedics (Salt Lake City, UT) from 2023 to 2026: 2 510(k) clearances. All are in product code HWC (Screw, Fixation, Bone). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided University of Utah, Department of Orthopaedics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like University of Utah, Department of…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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