Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K191263 |
Device Name |
Idys ALIF TiVac |
Applicant |
Clariance SAS |
18 rue Robespierre |
Beaurains,
FR
62217
|
|
Applicant Contact |
Fadwa Bahr |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street, Suite 2300 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 05/10/2019 |
Decision Date | 06/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|