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.

• 00643169465916 - Medtronic Reusable Instruments: 2024-12-30 TAP X1013176 4.5MM SOLID
• 00681490520089 - n/a: 2024-12-30 INSTRUMENT 8756412 DISTRACTOR PIN 12MM
• 20763000710525 - CD Horizon™ ModuLeX™ Spinal System: 2024-12-23 DRMAS 559200101 HEAD W/2 SET SCREWS
• 20763000710532 - CD Horizon™ ModuLeX™ Spinal System: 2024-12-23 RDRMAS 559200102 HEAD W/2 SET SCREWS
• 00763000857172 - VERTE-STACK® Spinal System: 2024-12-16 SPACER 6277441 CORNERSTONE PSR 4X14X11MM
• 00763000857387 - VERTE-STACK® Spinal System: 2024-12-16 SPACER 6277006 PSR STRUT 6 X 14 X 11MM
• 00763000868475 - CORNERSTONE® PSR Cervical Fusion System: 2024-12-16 IMPLANT 6284641 PEEK CRV 14X11X6MM
• 00763000878818 - NA: 2024-12-16 INSTRUMENT 803-043 GUIDEWIRE