ISOBAR SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SCIEN'TX USA INC.

The following data is part of a premarket notification filed by Scien'tx Usa Inc. with the FDA for Isobar Spinal System.

Pre-market Notification Details

Device IDK013444
510k NumberK013444
Device Name:ISOBAR SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SCIEN'TX USA INC. 9800 METRIC BLVD. Austin,  TX  78758
ContactJoanna Droege
CorrespondentJoanna Droege
SCIEN'TX USA INC. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-17
Decision Date2001-11-16
Summary:summary

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