FDA.reportPublic FDA data

N/A

Primary DI
00613994104526
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0905353
Device description
INSTRUMENT X0905353 RIGHT HALF TUBE120MM
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994104526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994104526006139941045266139941045260613994104526

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft funnelA device designed to deliver bone graft filling material (autologous, allogeneic, xenogeneic, or synthetic) during an orthopaedic procedure to enable the filling of bone gaps intended to be fused. It is a funnel-shaped device; the funnel being bowl-shaped with the ability to hold back the filling material depending upon the angle of tilt applied by the surgeon, and a long, thin tube that can be inserted into the site to be filled, e.g., a cancellous bone graft being discharged into the posterior disc space of a vertebra. An orthopaedic graft inserter can be pushed down the funnel tube to press the graft material into the site. 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
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327053067NASTRYKER CORPORATIONNBH2021-09-09
07613327054613NASTRYKER CORPORATIONNBH2020-08-17
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07613327055665DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055672DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055689DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055696DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055702DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055719DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055726DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055733DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055740DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055757DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055764DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055771DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055788DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055795DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055801DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327054576Speed-LockSTRYKER CORPORATIONNBH2020-08-04
07613327062540Speed-LockSTRYKER CORPORATIONNBH2020-08-04
07613327053043NASTRYKER CORPORATIONNBH2020-05-31
07613327053050NASTRYKER CORPORATIONNBH2020-05-31
07613327053081NASTRYKER CORPORATIONNBH2020-05-31
07613327052916NASTRYKER CORPORATIONNBH2020-05-20
07613327054569Speed-LockSTRYKER CORPORATIONNBH2020-04-28
07613327057751Speed-LockSTRYKER CORPORATIONNBH2020-04-28
07613327052930NASTRYKER CORPORATIONNBH2020-04-23
07613327052978NASTRYKER CORPORATIONNBH2020-04-23
07613327053036NASTRYKER CORPORATIONNBH2020-04-23