Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K183141 |
Device Name |
LINK MP Monoblock Hip Prosthesis |
Applicant |
Waldemar Link GmbH & Co. KG |
Oststraße 4-10 |
Norderstedt,
DE
22844
|
|
Applicant Contact |
Andre von Malotki |
Correspondent |
Waldemar Link GmbH & Co. KG |
Oststraße 4-10 |
Norderstedt,
DE
22844
|
|
Correspondent Contact |
Andre von Malotki |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 11/13/2018 |
Decision Date | 02/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|