InflateFX® Gen II Fracture Management

GUDID 00643169348233

TOOLKIT IFXG2A SCOOP WITH MBVF

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit 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.

• 00643169652798 - CD HORIZON® SOLERA® Spinal System: 2024-07-16 ROD X0914082 DUAL BEND 5.5 CCM PLS L 400
• 00643169652804 - CD HORIZON® SOLERA Spinal System: 2024-07-16 ROD X0914083 DUAL BEND 5.5 CCM PLS X 490
• 00763000658687 - MSB Reusable Instruments: 2024-07-16 HOLDER EX0322005 PLATE
• 00763000825829 - CD Horizon™ ModuLeX™ Spinal System: 2024-07-16 DRIVER SHAFT 5596077 CANN RATCHET LOCK
• 00763000825836 - CD Horizon™ ModuLeX™ Spinal System: 2024-07-16 SHANK DRIVER 5596078 CANN RATCHET LOCK
• 00763000825843 - CD Horizon™ ModuLeX™ Spinal System: 2024-07-16 SHNK DRVR 5596079 CAN RTCH LCK DPTH STOP
• 00763000825850 - CD Horizon™ ModuLeX™ Spinal System: 2024-07-16 SHANK DRIVER 5597413 RATCHET LOCK
• 00763000825898 - CD Horizon™ ModuLeX™ Spinal System: 2024-07-16 DRIVER SHAFT NAV5596077 CANN RATCHT LOCK