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 IDK990118
510k NumberK990118
Device Name:ISOBAR SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SCIEN'TX USA INC. 9800 METRIC BLVD. Austin,  TX  78758
ContactDebbie De Los Santos
CorrespondentDebbie De Los Santos
SCIEN'TX USA INC. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-13
Decision Date1999-03-22
Summary:summary

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