Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K223069 |
Device Name |
Modular Rotating Hinge Knee Systems and Compatible Components |
Applicant |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Margaret Klippel |
Correspondent |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Margaret Klippel |
Regulation Number | 888.3510
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/30/2022 |
Decision Date | 04/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|