InflateFX® Gen II Fracture Management

GUDID 00643169348233

TOOLKIT IFXG2A SCOOP WITH MBVF

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00643169348233
• NIH Device Record Key: b36a588a-c87b-42e3-b5a6-9e8254bbdba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InflateFX® Gen II Fracture Management
• Version Model Number: IFXG2A
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169348233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041454

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00199150000708 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06180845 8MM X 45MM DL MODULAR
• 00199150000715 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06180850 8MM X 50MM DL MODULAR
• 00199150000722 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06180855 8MM X 55MM DL MODULAR
• 00199150000739 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06181045 10MM X 45MM DL MODULAR
• 00199150000746 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06181050 10MM X 50MM DL MODULAR
• 00199150000753 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06181055 10MM X 55MM DL MODULAR
• 00199150000760 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06181245 12MM X 45MM DL MODULAR
• 00199150000777 - Medtronic Reusable Instruments: 2025-06-30 TRIAL X06181250 12MM X 50MM DL MODULAR