Vertex Reconstruction System

GUDID 00613994666642

ROD G7755270 PRE-BENT 3.5 X 100MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00613994666642
• NIH Device Record Key: d9b6ab48-1917-4faf-b826-f51503092ec9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex Reconstruction System
• Version Model Number: G7755270
• 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: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994666642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180851

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

[00613994666642]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-27
• Device Publish Date: 2021-09-18

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• 00613994666642: ROD G7755270 PRE-BENT 3.5 X 100MM
• 00613994641908: ROD G7750087 COBALT CHROME 3.5 X 240MM
• 00613994641892: ROD G7750086 COBALT CHROME 3.5 X 120MM
• 00613994641670: ROD G7750020 TI 3.5 X 300MM
• 00613994641663: ROD G7750015 TI 3.5 X 240MM
• 00613994641656: ROD G7750010 TI 3.5 X 120MM