FDA applicant
Spinefrontier, Inc.
FDA records 24 decisions for Spinefrontier, Inc. (Beverly, MA) from 2007 to 2020: 24 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 61 predicates, 21 of them its own earlier devices. 22 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spinefrontier, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Spinefrontier, 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