FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00673978135892
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0398-022
Device description
MOD NUT STARTER SHAFT/SOCKET
Published
2022-11-27
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
KILPOSITIONER, SOCKET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KILPositioner, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673978135892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978135892006739781358926739781358920673978135892

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw starter/notcherA hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. 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
00840277133618Innomed, Inc.INNOMED, INC.KIL2026-04-21
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06974940306727endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
06974940306758endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
00840277133182Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133199Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133205Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133212Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133229Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133236Innomed, Inc.INNOMED, INC.KIL2026-02-06
06974940306680endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
06974940306697endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
00840277133021Innomed, Inc.INNOMED, INC.KIL2025-11-10
00840277132888Innomed, Inc.INNOMED, INC.KIL2025-10-14
00840277132765Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132772Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132789Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132796Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132802Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132833Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132734Innomed, Inc.INNOMED, INC.KIL2025-08-27
00840277132659Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132666Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132628Innomed, Inc.INNOMED, INC.KIL2025-08-04
00840277132611Innomed, Inc.INNOMED, INC.KIL2025-07-09
00840277132406Innomed, Inc.INNOMED, INC.KIL2025-06-25
00840277132390Innomed, Inc.INNOMED, INC.KIL2025-06-17
00840277132239Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132246Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132253Innomed, Inc.INNOMED, INC.KIL2025-06-04