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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 K060412
Device Name ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
Applicant
Australian Surgical Design & Manufacture
2530 Riva Rd., Suite 308
Annapolis,  MD  21401
Applicant Contact JAMES F LOGAN
Correspondent
Australian Surgical Design & Manufacture
2530 Riva Rd., Suite 308
Annapolis,  MD  21401
Correspondent Contact JAMES F LOGAN
Regulation Number888.3530
Classification Product Code
HRY  
Date Received02/16/2006
Decision Date 05/17/2006
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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