Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K191325 |
Device Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
Applicant |
Encore Medical, L.P.
9800 Metric Blvd.
Austin, TX 78758 US
Other 510(k) Applications for this Company
|
Contact |
Teffany Hutto
Other 510(k) Applications for this Contact |
Regulation Number |
888.3520
More FDA Info for this Regulation Number |
Classification Product Code |
HSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
05/16/2019 |
Decision Date |
07/16/2019 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|