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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 K030087
Device Name SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
Applicant
SPINAL CONCEPTS, INC.
5301 RIATA PARK COURT
BLDG F
AUSTIN,  TX  78727
Applicant Contact LISA PETERSON
Correspondent
SPINAL CONCEPTS, INC.
5301 RIATA PARK COURT
BLDG F
AUSTIN,  TX  78727
Correspondent Contact LISA PETERSON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received01/09/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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