Kyphon VuE Bone Cement and Kyphon Mixer

GUDID 00763000590970

BONE CEMENT CT01B KYPHON VUE W MIXER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00763000590970
• NIH Device Record Key: 8f6206d2-3f5c-4c5d-9059-fd9107bdf8ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kyphon VuE Bone Cement and Kyphon Mixer
• Version Model Number: CT01B
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000590970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220131

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

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: 2022-08-02
• Device Publish Date: 2022-07-25

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000663865 - n/a: 2025-07-28 DRILL BIT 7080513 STERILE 13MM
• 00763000856472 - Pyramesh® Implant System: 2025-07-28 MESH 905-412 PYRM 10 X 14 OVOID X 12MM
• 00763000856489 - Pyramesh® Implant System: 2025-07-28 MESH 905-415 PYRM 10 X 14 OVOID X 15MM
• 00763000856502 - Pyramesh® Implant System: 2025-07-28 MESH 905-508 PYRM 13 X 17 OVOID X 8MM
• 00763000856519 - Pyramesh® Implant System: 2025-07-28 MESH 905-509 PYRM 13 X 17 OVOID X 9MM
• 00763000856526 - Pyramesh® Implant System: 2025-07-28 MESH 905-511 PYRM 13 X 17 OVOID X 11MM
• 00763000856533 - Pyramesh® Implant System: 2025-07-28 MESH 905-512 PYRM 13 X 17 OVOID X 12MM
• 00763000856557 - Pyramesh® Implant System: 2025-07-28 MESH 905-520 PYRM 13 X 17 OVOID X 20MM