FDA.reportPublic FDA data

N/A

Primary DI
00643169063976
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0711449
Device description
TRIAL EX0711449 CROSSLINK TRIAL
Published
2017-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169063976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169063976006431690639766431690639760643169063976

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00721902298431TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0182015-08-18
00721902298448TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0202015-08-18
00721902298455TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0222015-08-18
00721902298462TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0242015-08-19
00721902298479TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0262015-08-18
00763000704483MSB CAPSTONE CONTROL™ Spinal System40016272026-07-20
00763000879556MSB Reusable Instruments5210-10222026-07-20
00763000992439MSB INFINITY OCT SystemG365PT40262026-07-20
00763000992446MSB INFINITY OCT SystemG365PT40282026-07-20
00763000993092MSB INFINITY OCT SystemG36555352026-07-20
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
18257200103096ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103102ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103119ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103126ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103133ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103140ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103157ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103164ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103522ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103539ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103546ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103553ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103560ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103577ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103584ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103591ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103607ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17