510(k) K101030

MODIFICATION TO HBS HEADLESS BONE SCREW by Biopro, Inc. — Product Code HWC

K101030 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "MODIFICATION TO HBS HEADLESS BONE SCREW". The FDA issued a decision of Substantially Equivalent on June 3, 2010. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Biopro, Inc. has at least 10 other 510(k) clearances on record.