The following data is part of a premarket notification filed by Clariance, Sas with the FDA for Idys Alif Zp 3dti.
| Device ID | K200920 |
| 510k Number | K200920 |
| Device Name: | Idys ALIF ZP 3DTi |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Clariance, SAS 18 Rue Robespierre Beaurains, FR 62217 |
| Contact | Fadwa Bahr |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-05-29 |