FDA.reportPublic FDA data

SafeOp 3

Primary DI
00190376509747
Brand
SafeOp 3
Company
ALPHATEC SPINE, INC.
Model
AIX11814
Device description
AIX Windows Tablet, Dark
Published
2026-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE
GWFStimulator, electrical, evoked response
GXYElectrode, cutaneous
GXZELECTRODE, NEEDLE
IKNElectromyograph, diagnostic
PDQNeurosurgical nerve locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GXYElectrode, CutaneousNeurology2
GXZElectrode, NeedleNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234092000
K252842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234092000SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.2024-04-19GWF
K252842000SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.2026-01-11GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376509747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376509747001903765097471903765097470190376509747

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840967110981AlphaGRAFT1002-1002015-09-24
00840967110998AlphaGRAFT1001-0102015-09-24
00840967111001AlphaGRAFT1001-1002015-09-24
00844856026711AlphaGRAFT1001-0502015-09-24
00844856026728AlphaGRAFT1002-0252015-09-24
00844856026735AlphaGRAFT1002-0502015-09-24
00844856032231Osseofix +213902016-10-28
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25
00190376652337CONTOUR3DAIX761042026-09-25
00190376668307CONTOUR3DAIX760002026-09-25
00190376733470CONTOUR3DC3DRODA2026-09-25
00190376778372InvictusVMRIN2026-08-19
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816312028614Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-08
00816312028621Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-08
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604388N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHGWF2026-10-01
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
10816312028673Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-09-21
05707480167579Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
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
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843908NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
08720791378462NeurosignTechnomed Engineering B.V.GXZ2026-08-14