510(k) K083226

SMITH & NEPHEW PEEK INTERFERENCE SCREW by Smith & Nephew Endoscopy, Inc. — Product Code MBI

K083226 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "SMITH & NEPHEW PEEK INTERFERENCE SCREW". The FDA issued a decision of Substantially Equivalent on January 30, 2009. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.