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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K013887
Device Name BACFIX SPINAL FIXATION SYSTEM
Applicant
Spinal Concepts, Inc.
12012 Technology Blvd., #100
Austin,  TX  78727
Applicant Contact DAVID M HOPPER
Correspondent
Spinal Concepts, Inc.
12012 Technology Blvd., #100
Austin,  TX  78727
Correspondent Contact DAVID M HOPPER
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received11/23/2001
Decision Date 02/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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