The following data is part of a premarket notification filed by Clariance, Sas with the FDA for Idys Alif Zp 3dti.
| Device ID | K192168 |
| 510k Number | K192168 |
| Device Name: | Idys ALIF ZP 3DTi |
| Classification | Intervertebral Fusion Device With Integrated Fixation, 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700780630486 | K192168 | 000 |
| 03700780630332 | K192168 | 000 |
| 03700780630325 | K192168 | 000 |
| 03700780630318 | K192168 | 000 |
| 03700780630301 | K192168 | 000 |
| 03700780630295 | K192168 | 000 |
| 03700780630288 | K192168 | 000 |
| 03700780630271 | K192168 | 000 |
| 03700780630264 | K192168 | 000 |
| 03700780630257 | K192168 | 000 |
| 03700780630240 | K192168 | 000 |
| 03700780630233 | K192168 | 000 |
| 03700780630226 | K192168 | 000 |
| 03700780630349 | K192168 | 000 |
| 03700780630356 | K192168 | 000 |
| 03700780630479 | K192168 | 000 |
| 03700780630462 | K192168 | 000 |
| 03700780630455 | K192168 | 000 |
| 03700780630448 | K192168 | 000 |
| 03700780630431 | K192168 | 000 |
| 03700780630424 | K192168 | 000 |
| 03700780630417 | K192168 | 000 |
| 03700780630400 | K192168 | 000 |
| 03700780630394 | K192168 | 000 |
| 03700780630387 | K192168 | 000 |
| 03700780630370 | K192168 | 000 |
| 03700780630363 | K192168 | 000 |
| 03700780630783 | K192168 | 000 |