Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K211768 |
Device Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Applicant |
Waldemar Link GmbH & Co. KG
Oststra▀e 4-10
Norderstedt 22844 DE
Other 510(k) Applications for this Company
|
Contact |
Stefanie Fuchs
Other 510(k) Applications for this Contact |
Regulation Number |
888.3510
More FDA Info for this Regulation Number |
Classification Product Code |
KRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/08/2021 |
Decision Date |
06/30/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|