ARTiC-XL™ Spinal System
GUDID 00643169838000
TRIAL 54301825 L 30 HT 18 DEG 25
MEDTRONIC SOFAMOR DANEK, INC.
Spinal implant trial Spinal implant trial| Primary Device ID | 00643169838000 |
| NIH Device Record Key | d5d79b5e-4aa6-4a1a-b31b-d6f1425e76a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARTiC-XL™ Spinal System |
| Version Model Number | 54301825 |
| 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
| 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 | 00643169838000 [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 |
[00643169838000]
Moist Heat or Steam Sterilization
[00643169838000]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2017-10-27 |
On-Brand Devices [ARTiC-XL™ Spinal System]
| 00643169838123 | TRIAL 54501835 L 50 HT 18 DEG 35 |
| 00643169838116 | TRIAL 54501535 L 50 HT 15 DEG 35 |
| 00643169838109 | TRIAL 54501825 L 50 HT 18 DEG 25 |
| 00643169838093 | TRIAL 54501525 L 50 HT 15 DEG 25 |
| 00643169838086 | TRIAL 54501225 L 50 HT 12 DEG 25 |
| 00643169838079 | TRIAL 54401835 L 40 HT 18 DEG 35 |
| 00643169838062 | TRIAL 54401535 L 40 HT 15 DEG 35 |
| 00643169838055 | TRIAL 54401825 L 40 HT 18 DEG 25 |
| 00643169838048 | TRIAL 54401525 L 40 HT 15 DEG 25 |
| 00643169838031 | TRIAL 54401225 L 40 HT 12 DEG 25 |
| 00643169838024 | TRIAL 54301835 L 30 HT 18 DEG 35 |
| 00643169838000 | TRIAL 54301825 L 30 HT 18 DEG 25 |
| 00643169837997 | TRIAL 54301525 L 30 HT 15 DEG 25 |
| 00643169837980 | TRIAL 54301225 L 30 HT 12 DEG 25 |
| 00643169838017 | TRIAL 54301535 L 30 HT 15 DEG 35 |
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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