TIGER SPINE SYSTEM

Orthosis, Spinal Pedicle 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 IDK120696
510k NumberK120696
Device Name:TIGER SPINE SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant CORELINK LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
CORELINK LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-07
Decision Date2012-04-02
Summary:summary

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