Capstone Control Spinal System

GUDID 00643169677890

SPACER 4031522 CONTROL 24 DEG 15X22

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00643169677890
• NIH Device Record Key: 86bf5d22-d860-4024-8d89-876062fd7dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capstone Control Spinal System
• Version Model Number: 4031522
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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

• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter
• Angle: 24 degree
• Height: 15 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169677890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171107

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-02
• Device Publish Date: 2018-09-01

On-Brand Devices [Capstone Control Spinal System]

• 00643169677920: SPACER 4031822 CONTROL 24 DEG 18X22
• 00643169677913: SPACER 4031722 CONTROL 24 DEG 17X22
• 00643169677906: SPACER 4031622 CONTROL 24 DEG 16X22
• 00643169677890: SPACER 4031522 CONTROL 24 DEG 15X22
• 00643169677883: SPACER 4031422 CONTROL 24 DEG 14X22
• 00643169677876: SPACER 4031322 CONTROL 24 DEG 13X22
• 00643169674806: SPACER 4031527 CONTROL 24 DEG 15X27