FDA.report

Medtronic Reusable Instruments

Primary DI
00763000286729
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0619010
Device description
POSITIONER EX0619010 5.5/6.0 HEAD
Published
2022-10-11
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
KILPOSITIONER, SOCKET

Product Code Classifications

CodeDeviceSpecialtyClass
KILPositioner, SocketOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000286729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000286729007630002867297630002867290763000286729

GMDN Terms

TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. 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

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