Idys™- TLIF TiVac 41532912-S
GUDID 03700780628674
TLIF cage
CLARIANCE
Metal-polymer composite spinal interbody fusion cage| Primary Device ID | 03700780628674 |
| NIH Device Record Key | b8d7b10d-1ad7-41bd-9ec2-4a9426e39e5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Idys™- TLIF TiVac |
| Version Model Number | 41532912-S |
| Catalog Number | 41532912-S |
| Company DUNS | 296568400 |
| Company Name | CLARIANCE |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 7738687041 |
| s.chambat@clariance-spine.us |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700780628674 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183259
FDA Product Code
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-03-06 |
On-Brand Devices [Idys™- TLIF TiVac]
| 03700780628797 | TLIF cage |
| 03700780628780 | TLIF cage |
| 03700780628773 | TLIF cage |
| 03700780628766 | TLIF cage |
| 03700780628759 | TLIF cage |
| 03700780628742 | TLIF cage |
| 03700780628735 | TLIF cage |
| 03700780628728 | TLIF cage |
| 03700780628711 | TLIF cage |
| 03700780628704 | TLIF cage |
| 03700780628698 | TLIF cage |
| 03700780628681 | TLIF cage |
| 03700780628674 | TLIF cage |
| 03700780628667 | TLIF cage |
| 03700780628650 | TLIF cage |
| 03700780628643 | TLIF cage |
| 03700780628636 | TLIF cage |
| 03700780628322 | TLIF Cage |
Trademark Results [Idys]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IDYS 79237665 5682795 Live/Registered |
CLARIANCE 2018-04-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.