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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 K102834
Device Name ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
Applicant
Kinamed, Incorporated
820 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact ANTHONY ROSE
Correspondent
Kinamed, Incorporated
820 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact ANTHONY ROSE
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received09/29/2010
Decision Date 01/12/2011
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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