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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K021564
Device Name INCOMPASS SPINAL FIXATION SYSTEM
Applicant
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Applicant Contact DAVID M HOOPER
Correspondent
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Correspondent Contact DAVID M HOOPER
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received05/13/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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