Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K203532 |
Device Name |
BI-MENTUM™ ALTRX® Dual Mobility Liner |
Applicant |
Depuy Ireland UC |
Loughbeg Ringaskiddy |
Co. Cork,
IE
|
|
Applicant Contact |
Erin Combs |
Correspondent |
Depuy Ireland UC |
Loughbeg Ringaskiddy |
Co. Cork,
IE
|
|
Correspondent Contact |
Floriane Heinrich |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/02/2020 |
Decision Date | 04/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|