FDA applicant
Fusion Orthopedics, LLC
FDA records 13 decisions for Fusion Orthopedics, LLC (Mesa, AZ) from 2016 to 2024: 13 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 161 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Fusion Orthopedics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fusion Orthopedics, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Fusion Orthopedics, LLC’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 “Fusion”
FDA records each applicant name separately; these may or may not be the same firm.