Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K210893 |
Device Name |
Restoration Anatomic Shell |
Applicant |
Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Alexandra Kirby |
Correspondent |
Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Alexandra Kirby |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 03/25/2021 |
Decision Date | 04/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|