ARTiC-L™ Spinal System
GUDID 00763000085407
TRIAL 5300800 L 30 HT 8 DEG 0 FIXED
MEDTRONIC SOFAMOR DANEK, INC.
Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial| Primary Device ID | 00763000085407 |
| NIH Device Record Key | 1d64ea91-571d-494f-b130-44c2a36604c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARTiC-L™ Spinal System |
| Version Model Number | 5300800 |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| 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 | 00763000085407 [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 |
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
[00763000085407]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-10 |
| Device Publish Date | 2023-03-02 |
On-Brand Devices [ARTiC-L™ Spinal System]
| 00763000085391 | TRIAL 5251500 L 25 HT 15 DEG 0 FIXED |
| 00763000085384 | TRIAL 5251400 L 25 HT 14 DEG 0 FIXED |
| 00763000085339 | TRIAL 5250900 L 25 HT 9 DEG 0 FIXED |
| 00763000085414 | TRIAL 5350800 L 35 HT 8 DEG 0 FIXED |
| 00763000085407 | TRIAL 5300800 L 30 HT 8 DEG 0 FIXED |
| 00763000085322 | TRIAL 5250800 L 25 HT 8 DEG 0 FIXED |
Trademark Results [ARTiC-L]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTIC-L 87290814 5638538 Live/Registered |
Warsaw Orthopedic, Inc. 2017-01-05 |
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