TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

CORELINK LLC

The following data is part of a premarket notification filed by Corelink Llc with the FDA for Tiger Occipital-cervical-thoracic Spinal Fixation System.

Pre-market Notification Details

Device IDK132504
510k NumberK132504
Device Name:TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant CORELINK LLC 1331 H STREET NW, 12TH FLOOR Washington,  DC  20005
ContactJustin Eggleton
CorrespondentJustin Eggleton
CORELINK LLC 1331 H STREET NW, 12TH FLOOR Washington,  DC  20005
Product CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-12
Decision Date2013-11-25
Summary:summary

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