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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 Interlaminal
510(k) Number K951846
Device Name MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
Applicant
Alphatec Mfg., Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Alphatec Mfg., Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received04/20/1995
Decision Date 02/14/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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