510(k) K950704

K4 BONE SCREW SYSTEM by Kinetikos Medical, Inc. — Product Code HWC

K950704 is an FDA 510(k) premarket notification submitted by Kinetikos Medical, Inc. for the device "K4 BONE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 1995. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Kinetikos Medical, Inc. has at least 10 other 510(k) clearances on record.