FDA applicant
Reliance Medical Systems, LLC
FDA records 27 decisions for Reliance Medical Systems, LLC (Bountiful, UT) from 2007 to 2022: 27 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 202 predicates, 43 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Reliance Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Reliance Medical Systems, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Reliance Medical Systems, 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 “Reliance”
FDA records each applicant name separately; these may or may not be the same firm.