FDA.report

n/a

Primary DI
00643169092020
Brand
n/a
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0911034
Device description
CORKSCREW EX0911034 MINI
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWICORKSCREW

Product Code Classifications

CodeDeviceSpecialtyClass
HWICorkscrewOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169092020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169092020006431690920206431690920200643169092020

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00199150015429CD HORIZON® Spinal System593290202026-03-21
00199150015436CD HORIZON® Spinal System593290212026-03-21
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500052026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemNAV36062002026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500302026-03-21
00199150039524n/a36500042026-03-22
00199150044016Medtronic Reusable Instruments and Accessories65500252026-03-22
00199150051212Medtronic Reusable Instruments and AccessoriesRBT0901012026-03-22
00199150062263Medtronic Reusable InstrumentsEX10122552026-03-20
00199150062270Medtronic Reusable InstrumentsEX10122752026-03-20
00199150062287Medtronic Reusable InstrumentsEX10122902026-03-20
00199150066872Medtronic Reusable InstrumentsEX11250062026-03-20
00199150067343Medtronic Reusable InstrumentsEX12250162026-03-22
00199150067459Medtronic Reusable InstrumentsEX12250172026-03-20
00199150069675Medtronic Reusable InstrumentsX01260012026-03-20
00763000710194Medtronic Reusable Instruments and Accessories65520282026-03-22
00763000869069CD HORIZON® Spinal System593290142026-03-21
00763000869076CD HORIZON® Spinal System593290152026-03-21
00763000869090CD HORIZON® Spinal System593290172026-03-21
00763000869106CD HORIZON® Spinal System593290182026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776416683MillenniumAvalign Technologies, Inc.HWI2026-02-16
00190776402471MillenniumAvalign Technologies, Inc.HWI2025-06-23
00810123207916Adler Instrument CompanyAdler, Inc.HWI2024-10-18
00841036284923N/ABIOMET MICROFIXATION, INCHWI2024-09-25
00822409100798N/AOrtho Development CorporationHWI2023-10-06
00190776264499AvalignAvalign Technologies, Inc.HWI2023-09-28
00190776292799MILLENNIUMAvalign Technologies, Inc.HWI2023-09-28
07898506815272QuinelatoSchobell Industrial LtdaHWI2023-07-06
54026704810999PILLINGTELEFLEX INCORPORATEDHWI2022-12-08
00842331156663Novo Surgical Inc. NOVO SURGICAL, INC.HWI2022-11-12
00673978058436Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-14
00673978129471Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00673978131016Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00190776183028MillenniumAVALIGN TECHNOLOGIES, INC.HWI2021-11-01
00190776183035MillenniumAVALIGN TECHNOLOGIES, INC.HWI2021-11-01
00190776183042MillenniumAVALIGN TECHNOLOGIES, INC.HWI2021-11-01
00887868482854Cinch Modular AttachmentsBiomet Orthopedics, LLCHWI2021-03-24
00190660082734Ambler SurgicalAMBLER SURGICAL CORP.HWI2021-01-04
00889024595491Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595507Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595514Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595521Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595538Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595545Microfracture AwlZimmer, Inc.HWI2020-10-26
00841036284985N/ABIOMET MICROFIXATION, INCHWI2020-06-30
00847538010510DePuy SythesSYMMETRY MEDICAL INC.HWI2020-05-19
00847538010619DePuy SythesSYMMETRY MEDICAL INC.HWI2020-05-19
00880304608450CINCH MODULAR ATTACHMENTSBiomet Orthopedics, LLCHWI2020-05-15
04038653154586AESCULAPAesculap AGHWI2020-04-21
04038653154593AESCULAPAesculap AGHWI2020-04-21