FDA.reportPublic FDA data

ATEC Light Cable System

Primary DI
00190376508085
Brand
ATEC Light Cable System
Company
ALPHATEC SPINE, INC.
Model
169-510-S
Device description
LIF Illumination System, Sterile
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDGRetractor, fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376508085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376508085001903765080851903765080850190376508085

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
602465783
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376632919Invictus19869-N2026-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435240MillenniumAvalign Technologies, Inc.FDG2026-10-19
G141572101010Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210110Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210310Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210630Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210690Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210870Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210920Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G1415543110400Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157204210Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210130Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210200Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572103590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210570Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210670Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572107270Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210830Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
00840329838867N/ABLACK & BLACK SURGICAL, INC.FDG2026-09-29
G425110676LSI0My MedicalMy Medical Store LLCFDG2026-05-04
G425110686LSI0My MedicalMy Medical Store LLCFDG2026-05-04
00812432023140Medtronic Surgical Illuminator - TubeLumitex, Inc.FDG2026-04-17
00812432023157Medtronic Surgical Illuminator - BladeLumitex, Inc.FDG2026-04-17
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432021559Lumitex MD 3.75mm ACMI Reusable Light CableLumitex, Inc.FDG2026-01-29
00812432023164Medtronic 4mm Universal Reusable Light CableLumitex, Inc.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLumitex, Inc.FDG2026-01-07