510(k) Report

FDA applicant

Conmed Linvatec

Largo, FL21 decisions2005–20115 recalls

FDA records 21 decisions for Conmed Linvatec (Largo, FL) from 2005 to 2011: 21 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRX (Arthroscope). Its devices cite 60 predicates, 6 of them its own earlier devices. 5 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 Conmed Linvatec’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 52008: 42009: 32010: 32011: 1
2007high 5 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2026

2009: 12011: 22013: 12026 (partial year): 1
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Conmed”

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