ISOBAR SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

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 IDK013447
510k NumberK013447
Device Name:ISOBAR SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SCIEN'TX USA INC. 9800 METRIC BLVD. Austin,  TX  78758
ContactJoanna Dreoge
CorrespondentJoanna Dreoge
SCIEN'TX USA INC. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-17
Decision Date2002-01-15
Summary:summary

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