ARTiC-L™ Spinal System
GUDID 00763000085384
TRIAL 5251400 L 25 HT 14 DEG 0 FIXED
MEDTRONIC SOFAMOR DANEK, INC.
Spinal implant trial| Primary Device ID | 00763000085384 |
| NIH Device Record Key | 60639bdf-4fd6-4156-992c-0908775d140f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARTiC-L™ Spinal System |
| Version Model Number | 5251400 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000085384 [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 |
[00763000085384]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-15 |
| Device Publish Date | 2019-03-07 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.