Idys™ TLIF 3DTi Cages
Intervertebral Fusion Device With Bone Graft, Lumbar
CLARIANCE, SAS
The following data is part of a premarket notification filed by Clariance, Sas with the FDA for Idys™ Tlif 3dti Cages.
Pre-market Notification Details
| Device ID | K172465 |
| 510k Number | K172465 |
| Device Name: | Idys™ TLIF 3DTi Cages |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CLARIANCE, SAS 18 Rue Robespierre Beaurains, FR 62217 |
| Contact | Pascal Rokegem |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2017-12-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700780625758 | K172465 | 000 |
| 03700780625499 | K172465 | 000 |
| 03700780625505 | K172465 | 000 |
| 03700780625512 | K172465 | 000 |
| 03700780625529 | K172465 | 000 |
| 03700780625536 | K172465 | 000 |
| 03700780625543 | K172465 | 000 |
| 03700780625550 | K172465 | 000 |
| 03700780625574 | K172465 | 000 |
| 03700780625598 | K172465 | 000 |
| 03700780625611 | K172465 | 000 |
| 03700780625635 | K172465 | 000 |
| 03700780625659 | K172465 | 000 |
| 03700780625673 | K172465 | 000 |
| 03700780625697 | K172465 | 000 |
| 03700780625710 | K172465 | 000 |
| 03700780625734 | K172465 | 000 |
| 03700780625482 | K172465 | 000 |
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.