510(k) K132733

ORTHOHELIX SYNDESMOSIS FIXATION DEVICES by Orthohelix Surgical Designs, Inc. — Product Code HTN

K132733 is an FDA 510(k) premarket notification submitted by Orthohelix Surgical Designs, Inc. for the device "ORTHOHELIX SYNDESMOSIS FIXATION DEVICES". The FDA issued a decision of Substantially Equivalent on January 3, 2014. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Orthohelix Surgical Designs, Inc. has at least 10 other 510(k) clearances on record.