510(k) K183010

Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks by Smith & Nephew, Inc. — Product Code JWH

K183010 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks". The FDA issued a decision of Substantially Equivalent on Nov 28, 2018. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.