Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K193105 |
Device Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Applicant |
Conformis, Inc.
600 Technology Park Drive
Billerica, MA 01821 US
Other 510(k) Applications for this Company
|
Contact |
Nancy Giezen
Other 510(k) Applications for this Contact |
Regulation Number |
888.3560
More FDA Info for this Regulation Number |
Classification Product Code |
JWH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/08/2019 |
Decision Date |
03/13/2020 |
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 |
|