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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 K013444
Device Name ISOBAR SPINAL SYSTEM
Applicant
Scien'Tx USA, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact JOANNA DROEGE
Correspondent
Scien'Tx USA, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact JOANNA DROEGE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received10/17/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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