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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 K013447
Device Name ISOBAR SPINAL SYSTEM
Applicant
SCIEN'TX USA INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact JOANNA DREOGE
Correspondent
SCIEN'TX USA INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact JOANNA DREOGE
Regulation Number888.3050
Classification Product Code
KWP  
Date Received10/17/2001
Decision Date 01/15/2002
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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