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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 K070681
Device Name NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
Applicant
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Applicant Contact PAULA MORGAN
Correspondent
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Correspondent Contact PAULA MORGAN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/12/2007
Decision Date 05/04/2007
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
Recalls CDRH Recalls
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