Device Classification Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K190439 |
Device Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
Applicant |
Engage UNI, LLC
5931 Brick Court, Suite 130
Winter Park, FL 32792 US
Other 510(k) Applications for this Company
|
Contact |
Nicholas Slater
Other 510(k) Applications for this Contact |
Regulation Number |
888.3535
More FDA Info for this Regulation Number |
Classification Product Code |
NJD
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/25/2019 |
Decision Date |
11/21/2019 |
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 |
|