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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/Metal/Polymer
510(k) Number K093567
Device Name ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
Applicant
Anova Implant Solutions, LLC
Two Maryland Farms Suite 120
Brentwood,  TN  37027
Applicant Contact WALTER SPIRES
Correspondent
Anova Implant Solutions, LLC
Two Maryland Farms Suite 120
Brentwood,  TN  37027
Correspondent Contact WALTER SPIRES
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/18/2009
Decision Date 02/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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