THREADED CR-Ti

GUDID 00721902170898

10MM X 14MM THREADED CR-TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00721902170898
• NIH Device Record Key: 37ecb776-5c3b-45fd-8c32-e4fe0db2d563
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: THREADED CR-Ti
• Version Model Number: 6180210
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902170898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012255

FDA Product Code

• JDK: Prosthesis, hip, cement restrictor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-06
• Device Publish Date: 2015-08-18

On-Brand Devices [THREADED CR-Ti]

• 00721902170898: 10MM X 14MM THREADED CR-TI
• 00721902170874: 8MM X 14MM THREADED CR-TI
• 00721902170645: 7MM X 14MM THREADED CR-TI
• 00721902170638: 6MM X 14MM THREADED CR-TI