KYPHON® Express™ Bone Filler Device

GUDID 00643169335844

BONE FILLER DEVICE F06A SIZE 2

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement dispenser

• Primary Device ID: 00643169335844
• NIH Device Record Key: f6c65f72-9905-4dae-a02d-8a3417f5ed6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® Express™ Bone Filler Device
• Version Model Number: F06A
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169335844 [Primary]

FDA Product Code

• KIH: DISPENSER, CEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-26

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00763000728373 - n/a: 2025-05-26 TRAY 981991005 ALOP RETRACTOR TRAY 5
• 00763000858407 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-26 SHANK 55901610200 ILIAC CN STER 11.5X100
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• 00763000858421 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-26 SHANK 55901610280 ILIAC CAN STER 11.5X80
• 00763000858438 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-26 SHANK 55901610290 ILIAC CAN STER 11.5X90