FDA.reportPublic FDA data

N/A

Primary DI
00613994329523
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
945SPK1004
Device description
PROBE 945SPK1004 SURGEON CONTROLLED
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE
GXZELECTRODE, NEEDLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062996000DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBESAxon Systems, Inc.2007-01-12GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994329523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994329523006139943295236139943295230613994329523

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system, line-poweredAn assembly of mains electricity (AC-powered) devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal System39910272026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal System39910322026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal System39911222026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal System39911272026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal System39911322026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal System39912222026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal System39912272026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05707480167593Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167609Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167630Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167661Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
08720791378462NeurosignTechnomed Engineering B.V.GXZ2026-08-14
08720791378486NeurosignTechnomed Engineering B.V.GXZ2026-08-14
08720791378509NeurosignTechnomed Engineering B.V.GXZ2026-08-14
08720791378523NeurosignTechnomed Engineering B.V.GXZ2026-08-14
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
08720791379117InomedTechnomed Engineering B.V.GXZ2026-07-22
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
08720791375140NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
00887517413673MAS PLIFNuvasive, Inc.ETN2026-04-25
00199150037407NIM™MEDTRONIC XOMED, INC.ETN2026-03-29
03662674000525PediGuard DSG ConnectSPINEGUARDETN2025-09-17
00810135960502Retropsoas ElectrodeNVision Biomedical Technologies, Inc.ETN2023-10-25
00810135960519Retropsoas ElectrodeNVision Biomedical Technologies, Inc.ETN2023-10-25
00810135960526Retropsoas ElectrodeNVision Biomedical Technologies, Inc.ETN2023-10-25
00810135960533Retropsoas ElectrodeNVision Biomedical Technologies, Inc.ETN2023-10-25
00810135960557Retropsoas ElectrodeNVision Biomedical Technologies, Inc.ETN2023-10-25