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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 K023644
Device Name MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
Applicant
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Applicant Contact AUDREY SWEARINGEN
Correspondent
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Correspondent Contact AUDREY SWEARINGEN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received10/30/2002
Decision Date 11/25/2002
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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