CAPSTONE® Spinal System

GUDID 00613994150882

SPACER X0905244 CAPSTONE VS PEK VBS END

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 00613994150882
• NIH Device Record Key: ec18d843-0fe0-4426-a43a-bfcdcca1339b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPSTONE® Spinal System
• Version Model Number: X0905244
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994150882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041556

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar
• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00613994150882]

Moist Heat or Steam Sterilization

[00613994150882]

Moist Heat or Steam Sterilization

[00613994150882]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-19

On-Brand Devices [CAPSTONE® Spinal System]

• 00613994806222: TRIAL 2980732 CAPSTONE 07 X 32MM
• 00613994692146: SPACER X0409367 CAPSTONE PEEK 6X36X14
• 00613994526298: SPACER X0708291 8X22 3 DEGREE
• 00613994526281: SPACER X0708292 10X22 3 DEGREE
• 00613994526274: SPACER X0708293 12X22 3 DEGREE
• 00613994526267: SPACER X0708294 8X22 6 DEGREE
• 00613994526250: SPACER X0708295 10X22 6 DEGREE
• 00613994526243: SPACER X0708296 12X22 6 DEGREE
• 00613994526236: SPACER X0708301 8X22 9 DEGREE
• 00613994526229: SPACER X0708302 10X22 9 DEGREE
• 00613994526212: SPACER X0708303 12X22 9 DEGREE
• 00613994526205: SPACER X0708304 8X26 3 DEGREE
• 00613994526199: SPACER X0708305 10X26 3 DEGREE
• 00613994526182: SPACER X0708306 12X26 3 DEGREE
• 00613994526175: SPACER X0708311 8X26 6 DEGREE
• 00613994526168: SPACER X0708312 10X26 6 DEGREE
• 00613994526151: SPACER X0708313 12X26 6 DEGREE
• 00613994526144: SPACER X0708314 8X26 9 DEGREE
• 00613994526137: SPACER X0708315 10X26 9 DEGREE
• 00613994526120: SPACER X0708316 12X26 9 DEGREE
• 00613994444202: SPACER 2991336 CAPSTONE PEEK 13X36
• 00613994387400: SPACER 2991526 CAPSTONE PEEK 15X26
• 00613994387394: SPACER 2991326 CAPSTONE PEEK 13X26
• 00613994387387: SPACER 2991126 CAPSTONE PEEK 11X26
• 00613994387370: SPACER 2990926 CAPSTONE PEEK 09X26
• 00613994387363: SPACER 2990726 CAPSTONE PEEK 07X26
• 00613994387356: SPACER 2990626 CAPSTONE PEEK 06X26
• 00613994387332: SPACER 2991522 CAPSTONE PEEK 15X22
• 00613994387325: SPACER 2991322 CAPSTONE PEEK 13X22
• 00613994387318: SPACER 2991122 CAPSTONE PEEK 11X22
• 00613994387301: SPACER 2990922 CAPSTONE PEEK 09X22
• 00613994387295: SPACER 2990722 CAPSTONE PEEK 07X22
• 00613994387288: SPACER 2990622 CAPSTONE PEEK 06X22
• 00613994387264: SPACER 2991536 CAPSTONE PEEK 15X36
• 00613994387240: SPACER 2991136 CAPSTONE PEEK 11X36
• 00613994387233: SPACER 2990936 CAPSTONE PEEK 09X36
• 00613994387226: SPACER 2990736 CAPSTONE PEEK 07X36
• 00613994387196: SPACER 2991532 CAPSTONE PEEK 15X32
• 00613994387189: SPACER 2991332 CAPSTONE PEEK 13X32
• 00613994387172: SPACER 2991132 CAPSTONE PEEK 11X32
• 00613994387165: SPACER 2990932 CAPSTONE PEEK 09X32
• 00613994387158: SPACER 2990732 CAPSTONE PEEK 07X32
• 00613994291042: SPACER 2990822 CAPSTONE PEEK 08X22
• 00613994291035: SPACER 2990826 CAPSTONE PEEK 08X26
• 00613994291028: SPACER 2990832 CAPSTONE PEEK 08X32
• 00613994291011: SPACER 2990836 CAPSTONE PEEK 08X36
• 00613994291004: SPACER 2991022 CAPSTONE PEEK 10X22
• 00613994290991: SPACER 2991026 CAPSTONE PEEK 10X26
• 00613994290984: SPACER 2991032 CAPSTONE PEEK 10X32
• 00613994290977: SPACER 2991036 CAPSTONE PEEK 10X36