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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
510(k) Number K121727
Device Name MOVATION KNEE SYSTEM
Applicant
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact WILLIAM GARZON
Correspondent
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact WILLIAM GARZON
Regulation Number888.3560
Classification Product Code
OIY  
Subsequent Product Code
JWH  
Date Received06/12/2012
Decision Date 08/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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