FDA applicant
OsteoCentric Technologies
FDA records 13 decisions for OsteoCentric Technologies (Logan, UT) from 2021 to 2026: 13 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and OUR (Sacroiliac Joint Fixation). Since 2016 its 510(k)s took a median of 67 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Osteocentric Technologies, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided OsteoCentric Technologies’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like OsteoCentric Technologies’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “OsteoCentric”
FDA records each applicant name separately; these may or may not be the same firm.