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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K033826
Device Name ORTHOPEDIC ALLIANCE SPINE SYSTEM
Applicant
ORTHOPEDIC ALLIANCE LLC
41558 EASTMAN DRIVE
SUITE A
MARIETTA,  CA  92562
Applicant Contact ROGER WILLIAMS
Correspondent
ORTHOPEDIC ALLIANCE LLC
41558 EASTMAN DRIVE
SUITE A
MARIETTA,  CA  92562
Correspondent Contact ROGER WILLIAMS
Regulation Number888.3070
Classification Product Code
MNI  
Date Received12/10/2003
Decision Date 07/01/2004
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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