Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K202032 |
Device Name |
Idys LLIF 3DTi |
Applicant |
Clariance, SAS |
18, rue Robespierre |
Beaurains,
FR
62217
|
|
Applicant Contact |
Fadwa Bahr |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street, 23rd Floor |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/22/2020 |
Decision Date | 04/01/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|