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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K983976
Device Name METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
Applicant
Metagen, LLC
428 Technology Dr. E.
Origen Center
Menomonie,  WI  54751
Applicant Contact WESLEY D JOHNSON
Correspondent
Metagen, LLC
428 Technology Dr. E.
Origen Center
Menomonie,  WI  54751
Correspondent Contact WESLEY D JOHNSON
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received11/09/1998
Decision Date 12/30/1998
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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