Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K181744 |
Device Name |
BI-MENTUM dual mobility system |
Applicant |
Serf |
85 Avenue des Bruyeres |
Decines,
FR
69150
|
|
Applicant Contact |
Jean-Lus Aurelle |
Correspondent |
Gloster Biomedical International |
577 N Hope Avenue |
Santa Barbara,
CA
93110
|
|
Correspondent Contact |
Catherine Gloster |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/02/2018 |
Decision Date | 12/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|