ISOBAR SEMI-RIGID SPINAL SYSTEM

Orthosis, Spinal Pedicle 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 Semi-rigid Spinal System.

Pre-market Notification Details

Device IDK991326
510k NumberK991326
Device Name:ISOBAR SEMI-RIGID SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle 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 CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-19
Decision Date1999-11-08
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.