FDA applicant
Centinel Spine, Inc.
FDA records 17 decisions for Centinel Spine, Inc. (West Chester, PA) from 2006 to 2026: 15 510(k) clearances and 2 original PMA approvals. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and OVD (Intervertebral Fusion Device With Integrated…). Its devices cite 41 predicates, 14 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Centinel Spine, LLC”, “Centinel Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Centinel Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Centinel Spine, Inc.’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