FDA.reportPublic FDA data

DSG Connect

Primary DI
03662674000549
Brand
DSG Connect
Company
SPINEGUARD
Model
DSG Connect App
Catalog number
D1SW0001
Device description
App to run on tablet to display PediGuard DSG Connect data.
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201454000DSG Connect TechnologySpineguard S.A.2021-02-10PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662674000549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662674000549036626740005493662674000549

GMDN Terms#

Term, Definition table
TermDefinition
Spinal surgery navigation radiology softwareA software program intended to display, analyse/process, and possibly acquire images of the spine, typically acquired via computed tomography (CT) or fluoroscopic x-ray, primarily to assist with the navigation/positioning of surgical instruments, implants, and/or the patient during spinal surgery [computer assisted surgery (CAS)]. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
+33145184519qara@spineguard.com

Regulatory Flags#

DUNS number
260589566
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662674000525PediGuard DSG ConnectPediGuard DSG Connect Curv XSP1-AU5512025-09-17
03662674000068CANNULATED PEDIGUARDCANNULATED PEDIGUARD HANDLEP2HE10002016-08-29
03662674000099CANNULATED PEDIGUARDCANNULATED PEDIGUARD STARTER STYLET - BEVELP2ST10502018-10-22
03662674000174PEDIGUARD THREADEDDSG Pin 1D1PU00012016-08-29
03662674000389PEDIGUARD THREADEDSTARTER Pin 5D1SP00052016-12-26
03662674000570PEDIGUARD THREADED DSG Pin 6D1PU00062025-09-29
03662674000594CANNULATED PEDIGUARDNeedle XS, Trocar, 130mmP2ND22012025-09-18
03662674000495PediGuard DSG ConnectPediGuard DSG Connect Ø2.5P1-AU5132025-09-17
03662674000501PediGuard DSG ConnectPediGuard DSG Connect CurvP1-AU5502025-09-17
03662674000518PediGuard DSG ConnectPediGuard DSG Connect Ø2.5 XSP1-AU5142025-09-17
03662674000556PEDIGUARD THREADED DSG Threaded Shaft L Ø5mmD1TA00202025-09-17
03662674000563PEDIGUARD THREADED DSG Threaded Shaft L Ø4.5mmD1TA00212025-09-17
03662674000471PediGuard DSG ConnectPediGuard DSG Connect Ø4.0P1-AU5112025-08-28
03662674000488PediGuard DSG ConnectPediGuard DSG Connect Ø3.2P1-AU5122025-08-28
03662674000006PEDIGUARD CLASSICPEDIGUARD TRI TIP 4.0mmP1-AU4112016-06-28
03662674000013PEDIGUARD CLASSICPEDIGUARD TRI TIP 3.2mmP1-AU4122016-08-22
03662674000020PEDIGUARD CLASSICPEDIGUARD TRI TIP 2.5mmP1-AU4132016-08-29
03662674000037PEDIGUARD CLASSICPEDIGUARD TRI TIP 2.5mm XSP1-AU4142016-08-29
03662674000044PEDIGUARD CURVPEDIGUARD CURVP1-AU4502016-08-29
03662674000051PEDIGUARD CURVPEDIGUARD CURV XSP1-AU4512016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
00860010951705NeuralytixNEURALYTIX, LLCPDQ2026-10-19
00810161901562EARP NERVE CUFF ELECTRODE, 5MMRETROPSOAS TECHNOLOGIES, LLCETN2026-10-16
00810161901548EARP NERVE CUFF ELECTRODE, 3MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
M68980801D160Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLCPDQ2026-05-04
00887517413673MAS PLIFNuvasive, Inc.ETN2026-04-25
00199150037407NIM™MEDTRONIC XOMED, INC.ETN2026-03-29
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
03662674000525PediGuard DSG ConnectSPINEGUARDPDQ2025-09-17
03662674000525PediGuard DSG ConnectSPINEGUARDETN2025-09-17