Data / Medical devices / France / Spineguard, SA

Spineguard, SA: FDA-registered device maker in Vincennes Paris, France, 6 510(k) clearances

Name: Spineguard, SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spineguard, SA is registered with the FDA (registration 3008102049) in Vincennes Paris, France. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008102049
Address: 10, Cours Louis Lumiere, Vincennes Paris, France, 94300
Owner or operator: SpineGuard, SA (10031002)
Roles: Manufacturer, Specification developer
First device listed: December 31, 2009
Registered through: 2026
Brand names listed: Cannulated PediGuard Cannula 120mm, Cannulated PediGuard Stylet - Trocar, Cannulated PediGuard Stylet - Trocar - 120mm, Cannulated PediGuard Stylet Bevel - 120mm, Cannulated Pediguard Stylet - Bevel, Cannulated PsiFGuard, DSG Connect App, DSG Connect Handle and more

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Specification developer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Sacroiliac Joint Guidewire Placement Device	SCY	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer, Specification developer	accessdata.fda.gov
Stylet, Surgical, General & Plastic Surgery	GAH	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 26, 2024	K241895	Cannulated PsiFGuard	SCY	Substantially Equivalent	Spineguard	accessdata.fda.gov
March 31, 2022	K220160	PediGuard Threaded	PDQ	Substantially Equivalent	Spineguard S.A.	accessdata.fda.gov
February 10, 2021	K201454	DSG Connect Technology	PDQ	Substantially Equivalent	Spineguard S.A.	accessdata.fda.gov
January 12, 2017	K162884	SpineGuard DSG Zavation Screw System	HBG	Substantially Equivalent	Spineguard S.A.	accessdata.fda.gov
June 10, 2016	K152747	DSG Threaded Drill System	PDQ	Substantially Equivalent	Spineguard S.A.	accessdata.fda.gov
January 23, 2015	K143159	Cannulated 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 XS	PDQ	Substantially Equivalent	Spineguard S.A.	accessdata.fda.gov

Compare with other makers

Updated September 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.