Cure 2.0 Anterior Cervical Plate (ACP) 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 2.0 Anterior Cervical Plate (acp) System.

Pre-market Notification Details

Device IDK210286
510k NumberK210286
Device Name:Cure 2.0 Anterior Cervical Plate (ACP) 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 Received2021-02-02
Decision Date2021-03-18

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