Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K233261 |
Device Name |
Global Modular Replacement System |
Applicant |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
325 Corporate Dr. |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Denise Daugert |
Correspondent |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
325 Corporate Dr. |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Denise Daugert |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/29/2023 |
Decision Date | 12/08/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|