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SPINEGUARD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075665243007566524SPINEGUARD, INC.1Y2026-01-011434 Spruce Street Suite 100 Boulder CO US 80302
30081020493008102049SPINEGUARD, SA1N2026-01-0110, Cours Louis Lumiere Vincennes Paris FR 94300

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03662674000495PediGuard DSG Connect - PediGuard DSG Connect Ø2.5+33145184519qara@spineguard.com
03662674000556PEDIGUARD THREADED - DSG Threaded Shaft L Ø5mm+33145184519qara@spineguard.com
03662674000563PEDIGUARD THREADED - DSG Threaded Shaft L Ø4.5mm+33145184519qara@spineguard.com
03662674000570PEDIGUARD THREADED - DSG Pin 6+33145184519qara@spineguard.com
03662674000594CANNULATED PEDIGUARD - Needle XS, Trocar, 130mm+33145184519qara@spineguard.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1112661967821726K241895Cannulated PsiFGuardSCY2024-09-26
1112661859436704K201454DSG Connect TechnologyPDQ2021-02-10
1112661764638694K162884SpineGuard DSG Zavation Screw SystemHBG2017-01-12
1112661728959906K152747DSG Threaded Drill SystemPDQ2016-06-10
1112661272040113K143159Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XSPDQ2015-01-23
1112661107687657K123390PEDIGUARD NERVE DETECTOR SYSTEMPDQ2013-08-08
1112661887317558K030526PEDIGUARD NERVE DETECTOR SYSTEMGWF2004-12-29
1112661037425993
1112661236871984
1112661506355543
1112662031216911

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PDQ42021-02-10
SCY12024-09-26
HBG12017-01-12
GWF12004-12-29

PMN#

GUDID#

49 records. Showing 1-40. Next