510(k) K013107

BIOABSORBABLE INTERFERENCE SCREW MEGAFIX by Karl Storz Endoscopy — Product Code HWC

K013107 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "BIOABSORBABLE INTERFERENCE SCREW MEGAFIX". The FDA issued a decision of Substantially Equivalent on February 26, 2002. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.