510(k) K000590

LATERAL PIVOT INSERT by Encore Orthopedics, Inc. — Product Code JWH

K000590 is an FDA 510(k) premarket notification submitted by Encore Orthopedics, Inc. for the device "LATERAL PIVOT INSERT". The FDA issued a decision of Substantially Equivalent on May 11, 2000. 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. Encore Orthopedics, Inc. has at least 10 other 510(k) clearances on record.