510(k) K141004

INTRAOSSEOUS FIXATION SYSTEM by Orthohelix Surgical Designs, Inc. — Product Code HTY

K141004 is an FDA 510(k) premarket notification submitted by Orthohelix Surgical Designs, Inc. for the device "INTRAOSSEOUS FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 21, 2014. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Orthohelix Surgical Designs, Inc. has at least 10 other 510(k) clearances on record.