510(k) K915584

CRK CONDYLAR RESURFACING TOTAL KNEE by Implantology Corp. — Product Code JWH

K915584 is an FDA 510(k) premarket notification submitted by Implantology Corp. for the device "CRK CONDYLAR RESURFACING TOTAL KNEE". The FDA issued a decision of Substantially Equivalent on February 12, 1993. 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. Implantology Corp. has at least 8 other 510(k) clearances on record.