FDA applicant
Vertebron, Inc.
FDA records 11 decisions for Vertebron, Inc. (Stratford, CT) from 2004 to 2008: 11 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 37 predicates, 18 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vertebron, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Vertebron, 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