510(k) K082095

ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE by Smith & Nephew Endoscopy, Inc. — Product Code HTN

K082095 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE". The FDA issued a decision of Substantially Equivalent on October 21, 2008. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.