Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K161840 |
Device Name |
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated |
Applicant |
Waldemar Link GmbH & Co. KG |
Oststrabe 4-10 |
Norderstedt,
DE
22844
|
|
Applicant Contact |
Lorenz Runge |
Correspondent |
Waldemar Link GmbH & Co. KG |
Oststrabe 4-10 |
Norderstedt,
DE
22844
|
|
Correspondent Contact |
Andre von Malotki |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/05/2016 |
Decision Date | 03/16/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|