Reprocessing Instructions for the Capstone Inserter

GUDID 00613994846266

SHAFT 2990003 CAPSTONE THREADED INSERTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00613994846266
• NIH Device Record Key: a268e0a0-9e77-4d7f-9963-aa0bb1143598
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessing Instructions for the Capstone Inserter
• Version Model Number: 2990003
• 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: false
• 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
• 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	00613994846266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103731

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

[00613994846266]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-09-09

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 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