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.

• 00763000885144 - n/a: 2026-03-20 INSTRUMENT 2900249 SHUCKER
• 00199150066889 - Medtronic Reusable Instruments: 2026-03-10 AWL EX1125008
• 00199150066919 - Medtronic Reusable Instruments: 2026-03-10 ADJUSTER EX1125005 SAS HEAD
• 00763000880422 - Endoskeleton™ TCS Interbody System: 2026-03-10 BONE SCREW 5301-3516 TCS 3.5MM STD 16MM
• 00199150065974 - Medtronic Reusable Instruments: 2026-03-09 COUNTER TORQUE EX1125009 CLOSED
• 00199150066902 - Medtronic Reusable Instruments: 2026-03-09 DRIVER X0925004 T8/T10 HEXALOBE
• 00763000857936 - T2 STRATOSPHERE™ Expandable Corpectomy System: 2026-03-09 ENDCAP 4361168 16MM 8 DEGREE STERILE
• 00199150066025 - Medtronic Reusable Instruments: 2026-03-03 DILATOR EX1125002 INITIAL LONG