Cleared Traditional

CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503

K101100 · Conmed Linvatec · Orthopedic
Aug 2010
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K101100 is an FDA 510(k) clearance for the CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on August 26, 2010, 128 days after receiving the submission on April 20, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K101100 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2010
Decision Date August 26, 2010
Days to Decision 128 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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