Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K180930 |
Device Name |
EMPOWR VVC TIBIAL INSERT |
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 | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/10/2018 |
Decision Date | 07/09/2018 |
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
|
|
|