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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 K120177
Device Name SPINAL ELEMENTS CERCLAGE SYSTEM
Applicant
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Applicant Contact BENJAMIN A KIMBALL
Correspondent
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Correspondent Contact BENJAMIN A KIMBALL
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received01/20/2012
Decision Date 07/03/2012
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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