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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K101848
Device Name SAPPHIRE ANTERIOR CERVICAL PLATE 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 Number888.3060
Classification Product Code
KWQ  
Date Received07/01/2010
Decision Date 10/14/2010
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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