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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 K930515
Device Name ALPHA SPINAL SYSTEM
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  
Date Received02/01/1993
Decision Date 06/29/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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