510(k) K103309

OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS by Smith & Nephew Endoscopy, Inc. — Product Code MAI

K103309 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS". The FDA issued a decision of Substantially Equivalent on February 3, 2011. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.