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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K020356
Device Name ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
Applicant
Alphatec Mfg., Inc.
6110 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact ELLEN A HICKS
Correspondent
Alphatec Mfg., Inc.
6110 Corte Del Cedro
Carlsbad,  CA  92009
Correspondent Contact ELLEN A HICKS
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received02/04/2002
Decision Date 07/23/2002
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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