FDA applicant
Spinevision S.A.
FDA records 10 decisions for Spinevision S.A. (Antony, FR) from 2012 to 2022: 10 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OVE (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 75 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Spinevision, S.A.S.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spinevision S.A.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Spinevision S.A.’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) Report