510(k) K151615

TiTHON Staple with OsseoTi Technology by Biomet Manufacturing Corp — Product Code JDR

K151615 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "TiTHON Staple with OsseoTi Technology". The FDA issued a decision of Substantially Equivalent on October 2, 2015. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.