510(k) K162795

PROPHECY INVISION Preoperative Navigation Alignment System by Wrightmedicaltechnologyinc — Product Code HSN

K162795 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PROPHECY INVISION Preoperative Navigation Alignment System". The FDA issued a decision of Substantially Equivalent on Feb 22, 2017. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Wrightmedicaltechnologyinc has 301 other 510(k) clearances on record.