Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K191084 |
Device Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Applicant |
Optimotion Implants, LLC
5931 Brick Court, Suite 130
Winter Park, FL 32792 US
Other 510(k) Applications for this Company
|
Contact |
Dan Justin
Other 510(k) Applications for this Contact |
Regulation Number |
888.3565
More FDA Info for this Regulation Number |
Classification Product Code |
MBH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/24/2019 |
Decision Date |
04/07/2020 |
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 |
|