The following data is part of a premarket notification filed by Clariance, Sas with the FDA for Idys Llif 3dti.
Device ID | K202032 |
510k Number | K202032 |
Device Name: | Idys LLIF 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, 23rd Floor 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 | 2020-07-22 |
Decision Date | 2021-04-01 |