510(k) K123672

INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) by Inion OY — Product Code HWC

K123672 is an FDA 510(k) premarket notification submitted by Inion OY for the device "INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)". The FDA issued a decision of Substantially Equivalent on February 27, 2013. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Inion OY has at least 10 other 510(k) clearances on record.