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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K071380
Device Name MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
Applicant
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Applicant Contact PAULA MORGAN
Correspondent
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Correspondent Contact PAULA MORGAN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNI  
Date Received05/17/2007
Decision Date 08/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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