510(k) K162800

BLUEPRINT Patient Specific Instrumentation by Tornier S.A.S. — Product Code KWS

K162800 is an FDA 510(k) premarket notification submitted by Tornier S.A.S. for the device "BLUEPRINT Patient Specific Instrumentation". The FDA issued a decision of Substantially Equivalent on Feb 22, 2017. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Tornier S.A.S. has 115 other 510(k) clearances on record.