Cleared Traditional

CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR

K090835 · Linvatec Corp. · Orthopedic
Jun 2009
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K090835 is an FDA 510(k) clearance for the CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 22, 2009, 87 days after receiving the submission on March 27, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K090835 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2009
Decision Date June 22, 2009
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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