Device Classification Name |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K222835 |
Device Name |
Prophecy Preoperative Navigation Alignment System |
Applicant |
Wright Medical Technology, Inc. |
10801 Nesbitt Ave S. |
Bloomington,
MN
55437
|
|
Applicant Contact |
Paxia Her |
Correspondent |
Wright Medical Technology, Inc. |
10801 Nesbitt Ave S. |
Bloomington,
MN
55437
|
|
Correspondent Contact |
Paxia Her |
Regulation Number | 888.3110
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/20/2022 |
Decision Date | 01/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|