Primary Device ID | 00643169800502 |
NIH Device Record Key | 67aa0720-07a6-46aa-b98d-f52c7dccbee5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology |
Version Model Number | 53401225 |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169800502 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2017-10-27 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ARTIC-XL 87303941 not registered Live/Pending |
Warsaw Orthopedic, Inc. 2017-01-17 |