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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 K990721
Device Name ISOLOCK SPINAL SYSTEM
Applicant
Scien'Tx USA, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact DEBBIE DE LOS SANTOS
Correspondent
Scien'Tx USA, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact DEBBIE DE LOS SANTOS
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received03/05/1999
Decision Date 05/27/1999
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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