Cure™ Lumbar Plate System

Appliance, Fixation, Spinal Intervertebral Body

Meditech Spine, LLC

The following data is part of a premarket notification filed by Meditech Spine, Llc with the FDA for Cure™ Lumbar Plate System.

Pre-market Notification Details

Device IDK201136
510k NumberK201136
Device Name:Cure™ Lumbar Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta,  GA  30309
ContactBruce Dunaway
CorrespondentBruce Dunaway
Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta,  GA  30309
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-28
Decision Date2020-05-12

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