ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology
GUDID 00643169844209
TRAY 5332030 TI INTERBODY INSTRUMENTS
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00643169844209 |
| NIH Device Record Key | eb1bafcf-f779-4d44-9bb8-c17ed1108d6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology |
| Version Model Number | 5332030 |
| 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 | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169844209 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171689
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
[00643169844209]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-10-27 |
On-Brand Devices [ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology]
| 00643169844209 | TRAY 5332030 TI INTERBODY INSTRUMENTS |
| 00643169800595 | SPACER 53501835 50MM X 18MM 35 DEGREE TI |
| 00643169800588 | SPACER 53501535 50MM X 15MM 35 DEGREE TI |
| 00643169800571 | SPACER 53501825 50MM X 18MM 25 DEGREE TI |
| 00643169800564 | SPACER 53501525 50MM X 15MM 25 DEGREE TI |
| 00643169800557 | SPACER 53501225 50MM X 12MM 25 DEGREE TI |
| 00643169800540 | SPACER 53401835 40MM X 18MM 35 DEGREE TI |
| 00643169800533 | SPACER 53401535 40MM X 15MM 35 DEGREE TI |
| 00643169800526 | SPACER 53401825 40MM X 18MM 25 DEGREE TI |
| 00643169800519 | SPACER 53401525 40MM X 15MM 25 DEGREE TI |
| 00643169800502 | SPACER 53401225 40MM X 12MM 25 DEGREE TI |
| 00643169800496 | SPACER 53301835 30MM X 18MM 35 DEGREE TI |
| 00643169800489 | SPACER 53301535 30MM X 15MM 35 DEGREE TI |
| 00643169800472 | SPACER 53301825 30MM X 18MM 25 DEGREE TI |
| 00643169800465 | SPACER 53301525 30MM X 15MM 25 DEGREE TI |
| 00643169800458 | SPACER 53301225 30MM X 12MM 25 DEGREE TI |
| 00763000086305 | TRAY 5332030 TI INTERBODY INSTRUMENTS |
Trademark Results [ARTiC-XL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTIC-XL 87303941 not registered Live/Pending |
Warsaw Orthopedic, Inc. 2017-01-17 |
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