510(k) K000797

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 by Orthopaedic Biosystems, Ltd. — Product Code JDR

K000797 is an FDA 510(k) premarket notification submitted by Orthopaedic Biosystems, Ltd. for the device "OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01". The FDA issued a decision of Substantially Equivalent on April 3, 2000. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthopaedic Biosystems, Ltd. has at least 10 other 510(k) clearances on record.