Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K182468 |
Device Name |
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System |
Applicant |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
325 Corporate Dr. |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Shahrir Alam |
Correspondent |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
325 Corporate Dr. |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Krutanjali Shah |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/10/2018 |
Decision Date | 03/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|