Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K233724 |
Device Name |
28mm/38D MDM X3 Insert for MDM Liner |
Applicant |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Meenakshi Verma |
Correspondent |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Meenakshi Verma |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/21/2023 |
Decision Date | 03/11/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|