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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 K983260
Device Name MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
Applicant
SPINAL CONCEPTS, INC.
820O CAMERON RD., SUITE B-160
AUSTIN,  TX  78754
Applicant Contact TEENA M AUGOSTINO
Correspondent
SPINAL CONCEPTS, INC.
820O CAMERON RD., SUITE B-160
AUSTIN,  TX  78754
Correspondent Contact TEENA M AUGOSTINO
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received09/16/1998
Decision Date 10/21/1998
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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