510(k) K063584

STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 by Regeneration Technologies, Inc. — Product Code HWC

K063584 is an FDA 510(k) premarket notification submitted by Regeneration Technologies, Inc. for the device "STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937". The FDA issued a decision of Substantially Equivalent on May 9, 2007. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Regeneration Technologies, Inc. has at least 10 other 510(k) clearances on record.