Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K163595 |
Device Name |
IMPIX 3D Print Cages |
Applicant |
MEDICREA INTERNATIONAL S.A. |
5389 route de Strasbourg |
Rillieux-la-Pape,
FR
69140
|
|
Applicant Contact |
David Ryan |
Correspondent |
MEDICREA INTERNATIONAL S.A. |
5389 route de Strasbourg |
Rillieux-la-Pape,
FR
69140
|
|
Correspondent Contact |
David Ryan |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 12/21/2016 |
Decision Date | 11/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|