510(k) Report

FDA applicant

Linvatec Corporation D/B/A Conmed Linvatec

Largo, FL4 decisions2011–20136 recalls

FDA records 4 decisions for Linvatec Corporation D/B/A Conmed Linvatec (Largo, FL) from 2011 to 2013: 4 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HBC (Motor, Drill, Electric). Its devices cite 6 predicates, 1 of them its own earlier devices. 6 recalls are 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 Linvatec Corporation D/B/A Conmed Linvatec’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2011: 12012: 12013: 2
2011high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

6in 2012

2012: 6
2011high 6 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Linvatec Corporation D/B/A Conmed Linvatec by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Linvatec”

FDA records each applicant name separately; these may or may not be the same firm.