510(k) K101100

CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 by Conmed Linvatec — Product Code MAI

K101100 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503". The FDA issued a decision of Substantially Equivalent on August 26, 2010. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Conmed Linvatec has at least 10 other 510(k) clearances on record.