CAPSTONE® L Spinal System

GUDID 00643169132955

CAGE 2964436 CAPSTONE-L 6 DEG 14X36

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00643169132955
• NIH Device Record Key: fbdea7c4-dd9a-4dc1-9e3d-a736428c65c6
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CAPSTONE® L Spinal System
• Version Model Number: 2964436
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169132955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123978

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2016-04-17

On-Brand Devices [CAPSTONE® L Spinal System]

• 00643169133334: CAGE 2964444 CAPSTONE-L 6 DEG 14X44
• 00643169133198: CAGE 2964836 CAPSTONE-L 6 DEG 8X36
• 00643169133181: CAGE 2964840 CAPSTONE-L 6 DEG 8X40
• 00643169133174: CAGE 2964844 CAPSTONE-L 6 DEG 8X44
• 00643169133112: CAGE 2964036 CAPSTONE-L 6 DEG 10X36
• 00643169133105: CAGE 2964040 CAPSTONE-L 6 DEG 10X40
• 00643169133099: CAGE 2964044 CAPSTONE-L 6 DEG 10X44
• 00643169133037: CAGE 2964236 CAPSTONE-L 6 DEG 12X36
• 00643169133020: CAGE 2964240 CAPSTONE-L 6 DEG 12X40
• 00643169133013: CAGE 2964244 CAPSTONE-L 6 DEG 12X44
• 00643169132955: CAGE 2964436 CAPSTONE-L 6 DEG 14X36
• 00643169132948: CAGE 2964440 CAPSTONE-L 6 DEG 14X40
• 00643169249523: INSERTER 2982003 CAPSTONE L SLEEVED