Idys™ TLIF TiVac
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 Tivac.
Pre-market Notification Details
| Device ID | K183259 |
| 510k Number | K183259 |
| Device Name: | Idys™ TLIF TiVac |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Clariance SAS 18 Rue Robespierre Beaurains, FR 62217 |
| Contact | Clement Chaumont |
| 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 | 2018-11-21 |
| Decision Date | 2019-03-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700780628797 | K183259 | 000 |
| 03700780628636 | K183259 | 000 |
| 03700780628643 | K183259 | 000 |
| 03700780628650 | K183259 | 000 |
| 03700780628667 | K183259 | 000 |
| 03700780628674 | K183259 | 000 |
| 03700780628681 | K183259 | 000 |
| 03700780628698 | K183259 | 000 |
| 03700780628704 | K183259 | 000 |
| 03700780628711 | K183259 | 000 |
| 03700780628728 | K183259 | 000 |
| 03700780628735 | K183259 | 000 |
| 03700780628742 | K183259 | 000 |
| 03700780628759 | K183259 | 000 |
| 03700780628766 | K183259 | 000 |
| 03700780628773 | K183259 | 000 |
| 03700780628780 | K183259 | 000 |
| 03700780628322 | K183259 | 000 |
Trademark Results [Idys]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IDYS 79237665 5682795 Live/Registered |
CLARIANCE 2018-04-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.