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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 K052201
Device Name SOLANAS POSTERIOR STABILIZATION SYSTEM
Applicant
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Applicant Contact ELLEN A YARNALL
Correspondent
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Correspondent Contact ELLEN A YARNALL
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received08/12/2005
Decision Date 11/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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