Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K181203 |
Device Name |
Juliet Ti |
Applicant |
Spineart |
3 Chemin du Pré Fleuri |
Plan Les Ouates,
CH
1228
|
|
Applicant Contact |
Frank Pennesi |
Correspondent |
Spineart |
3 Chemin du Pré Fleuri |
Plan Les Ouates,
CH
1228
|
|
Correspondent Contact |
Frank Pennesi |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 05/07/2018 |
Decision Date | 06/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|