TIGER SPINE SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

CORELINK, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Tiger Spine System.

Pre-market Notification Details

Device IDK110321
510k NumberK110321
Device Name:TIGER SPINE SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant CORELINK, LLC 101 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
CORELINK, LLC 101 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-03
Decision Date2011-05-25
Summary:summary

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