Dakota ALIF Plate System

Appliance, Fixation, Spinal Intervertebral Body

Precision Spine, Inc.

The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Dakota Alif Plate System.

Pre-market Notification Details

Device IDK212937
510k NumberK212937
Device Name:Dakota ALIF Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Precision Spine, Inc. 2050 Executive Dr. Pearl,  MS  39208
ContactMichael Dawson
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 Received2021-09-15
Decision Date2021-11-04

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