Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
More FDA Info for this Device |
510(K) Number |
K183141 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Applicant |
Waldemar Link GmbH & Co. KG
Oststra▀e 4-10
Norderstedt 22844 DE
Other 510(k) Applications for this Company
|
Contact |
Andre von Malotki
Other 510(k) Applications for this Contact |
Regulation Number |
888.3353
More FDA Info for this Regulation Number |
Classification Product Code |
LZO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/13/2018 |
Decision Date |
02/08/2019 |
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 |
|