FDA applicant
Nexus Spine, LLC
FDA records 19 decisions for Nexus Spine, LLC (Salt Lake City, UT) from 2014 to 2026: 19 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OVD (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 77 predicates, 25 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Nexus Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nexus Spine, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Nexus Spine, 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 “Nexus”
FDA records each applicant name separately; these may or may not be the same firm.