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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 Interlaminal
510(k) Number K964404
Device Name BACFIX SPINAL FIXATION SYSTEM
Applicant
Spinal Concepts, Inc.
701 Brazos
Suite 500
Austin,  TX  78701
Applicant Contact ERIN MCGURK
Correspondent
Spinal Concepts, Inc.
701 Brazos
Suite 500
Austin,  TX  78701
Correspondent Contact ERIN MCGURK
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received11/04/1996
Decision Date 03/26/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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