DSG Threaded Drill System

Neurosurgical Nerve Locator

SPINEGUARD, S.A.

The following data is part of a premarket notification filed by Spineguard, S.a. with the FDA for Dsg Threaded Drill System.

Pre-market Notification Details

Device IDK152747
510k NumberK152747
Device Name:DSG Threaded Drill System
ClassificationNeurosurgical Nerve Locator
Applicant SPINEGUARD, S.A. 10 COURS LOUIS LUMIERE Vincennes,  FR 94300
ContactStephane Bette
CorrespondentJohn J. Smith
HOGAN LOVELLS US LLP 555 THIRTEENTH ST. Washington,  DC  20004
Product CodePDQ  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-23
Decision Date2016-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03662674000198 K152747 000
03662674000174 K152747 000

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