Cleared Special

CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM

K091549 · Linvatec Corp. · Orthopedic
Jun 2009
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K091549 is an FDA 510(k) clearance for the CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 23, 2009, 27 days after receiving the submission on May 27, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K091549 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2009
Decision Date June 23, 2009
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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