Medina Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Alliance Partners, LLC

The following data is part of a premarket notification filed by Alliance Partners, Llc with the FDA for Medina Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK201521
510k NumberK201521
Device Name:Medina Anterior Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Alliance Partners, LLC 14206 Northbrook Drive San Antonio,  TX  78232
ContactDesiree Crawford
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-08-06

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