510(k) Report

FDA applicant

Vertebron, Inc.

Stratford, CT11 decisions2004–20080 recalls

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, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Vertebron, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2008

2007: 12008: 3
2007high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vertebron, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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