NIM9Spine

GUDID 00613994244055

INSTRUMENT 9450067 SURFCE ELECTRD KT 8CH

MEDTRONIC SOFAMOR DANEK, INC.

Nerve-locating system

• Primary Device ID: 00613994244055
• NIH Device Record Key: 2c7244a0-77e8-434d-9aa9-76d2815c4248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIM9Spine
• Version Model Number: 9450067
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994244055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031510

FDA Product Code

• ETN: STIMULATOR, NERVE

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: 2018-07-06
• Device Publish Date: 2016-10-01

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00763000879563 - ENDOSKELETON® TCS: 2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE
• 00763000879587 - ENDOSKELETON® TCS: 2025-09-29 DRIVER 5210-1004 TCS NO 8 HEX STRAIGHT
• 00763000879600 - ENDOSKELETON® TCS: 2025-09-29 DRIVER 5210-1024 TCS NO 8 HEX U-JOINT
• 00763000879648 - Endoskeleton™ TCS Interbody System: 2025-09-29 AWL 5210-1062 TCS STRAIGHT FIXED 2MM
• 00763000879655 - Endoskeleton™ TCS Interbody System: 2025-09-29 AWL 5210-1063 TCS CURVED FIXED 2MM