510(k) K030848

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

K030848 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX". The FDA issued a decision of Substantially Equivalent on June 2, 2003. 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.