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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 K062371
Device Name PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Alphaspine, Inc.
765 E. 340 S.,
Suite 204
American Fork,  UT  84003
Applicant Contact MIKE ENSIGN
Correspondent
Alphaspine, Inc.
765 E. 340 S.,
Suite 204
American Fork,  UT  84003
Correspondent Contact MIKE ENSIGN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/14/2006
Decision Date 12/04/2006
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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