Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K191325 |
Device Name |
EMPOWR Partial Knee |
Applicant |
Encore Medical, L.P. |
9800 Metric Blvd. |
Austin,
TX
78758
|
|
Applicant Contact |
Teffany Hutto |
Correspondent |
Encore Medical, L.P. |
9800 Metric Blvd. |
Austin,
TX
78758
|
|
Correspondent Contact |
Teffany Hutto |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 05/16/2019 |
Decision Date | 07/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|