510(k) K934589

KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED by Kirschner Medical Corp. — Product Code JWH

K934589 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED". The FDA issued a decision of SN on July 13, 1994. 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. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.