Device Classification Name |
ankle arthroplasty implantation system
|
510(k) Number |
K223326 |
Device Name |
Axiom PSR System |
Applicant |
Restor3d |
404 Hunt St. Suite 500 |
Durham,
NC
27701
|
|
Applicant Contact |
Brianna Prindle |
Correspondent |
Restor3d |
311 W. Corporation St. |
Durham,
NC
27701
|
|
Correspondent Contact |
Brianna Prindle |
Regulation Number | 888.3110
|
Classification Product Code |
|
Date Received | 10/31/2022 |
Decision Date | 03/30/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|