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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, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K081293
Device Name UNIVATION UNICONDYLAR KNEE SYSTEM
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Applicant Contact LISA M BOYLE
Correspondent
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Correspondent Contact LISA M BOYLE
Regulation Number888.3530
Classification Product Code
HRY  
Date Received05/07/2008
Decision Date 09/22/2008
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
Recalls CDRH Recalls
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