Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K234025 |
Device Name |
22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads |
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 |
|
Date Received | 12/20/2023 |
Decision Date | 04/24/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|