Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K151008 |
Device Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Applicant |
Waldemar Link GmbH & Co. KG
Barkhausenweg 10
Hamburg 22339 DE
Other 510(k) Applications for this Company
|
Contact |
Helmut D Link
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 |
04/15/2015 |
Decision Date |
08/26/2015 |
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 |
|