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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 K050390
Device Name TAMARACK ANTERIOR THORACOLUNBAR
Applicant
Alphatec/Nexmed
6110 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact ELLEN A YARMALL
Correspondent
Alphatec/Nexmed
6110 Corte Del Cedro
Carlsbad,  CA  92009
Correspondent Contact ELLEN A YARMALL
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/16/2005
Decision Date 03/14/2005
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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