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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| 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.
| 00643169281165 - CD HORIZON® ASTUTE™ SPINAL SYSTEM | 2024-05-27 PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM |
| 00763000242503 - MSB Reusable Instruments | 2024-05-27 GRAFT DELIVERY 6061007 GUN HANDLE |
| 00763000914103 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823011 1/4 WIDE SHARP |
| 00763000914110 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823012 1/2 WIDE SHARP |
| 00763000940454 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420013 16DEG 16MM LARGE |
| 00763000940607 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420028 20DEG 14MM LARGE |
| 00763000940614 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420029 20DEG 16MM LARGE |
| 00763000940621 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420030 20DEG 18MM LARGE |
Trademark Results [InflateFX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFLATEFX 85441732 4265515 Live/Registered |
Kyphon SARL 2011-10-07 |
 INFLATEFX 85386999 4258595 Live/Registered |
Kyphon SARL 2011-08-02 |
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