SPINEGUARD, SA

FDA Device Registration & Listing · Vincennes Paris, FR · Registration 3008102049

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008102049
FEI Number
3008102049
Entity Name
SPINEGUARD, SA
City/State/Country
Vincennes Paris, FR
Establishment Address
10, Cours Louis Lumiere, Vincennes Paris 94300, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SpineGuard, SA (Owner Number: 10031002)
Owner / Operator Contact Address
10, cours Louis LUMIERE, Vincennes, FR-75 94300, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K143159
PMA Number
N/A

All Registered Proprietary Names

PediGuard DSG Plastic Sleeve SpineGuard PediGuard Threaded PediGuard 120mm Trocar Needle Cannulated PediGuard Cannula 120mm PediGuard Stiffer Cannula - Accessory DSG Threaded Drill Starter Pin DSG Connect Handle DSG Connect App PediGuard DSG Connect DSG Connect Handle DSG Handle Needle XS Cannulated PsiFGuard Cannulated PediGuard Stylet Bevel - 120mm PediGuard DSG Threaded Shaft PediGuard DSG Ratcheting Handle Cannulated Pediguard Stylet - Bevel Cannulated PediGuard Stylet - Trocar Cannulated PediGuard Stylet - Trocar - 120mm PediGuard XS PediGuard Needle#1 PediGuard Curv PediGuard Handle PediGuard Needle PediGuard Tri-Tip PediGuard Curv XS PediGuard Needle #2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2009-12-31
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2016-06-15
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2016-06-15
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-18
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-12-22
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2021-03-19
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2021-03-19
SCY Sacroiliac Joint Guidewire Placement Device Orthopedic Class 2 888.3040 2025-01-20
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2010-04-08
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2015-07-02
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2015-07-02

Official Correspondent

Stephane Bette

US Agent Details

Stephane Bette Business: SPINEGUARD Email: stephane.bette@spineguard.com Phone: (720) 7268085

Related Public Records

Same Entity

SpineGuard, SA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K833646 Edward Weck, Inc. PULSATRON NERVE LOCATOR/STIMULATOR 1984-02-10
K150005 Ndi Medical, LLC Checkpoint, Checkpoint Head & Neck 2015-02-19
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008102049. Last updated year: 2026. Please use registration number 3008102049 when referencing this establishment in official correspondence.
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