Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K152431 |
Device Name |
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating |
Applicant |
WALDEMAR LINK GMBH & CO. KG |
BARKHAUSENWEG 10 |
HAMBURG,
DE
22339
|
|
Applicant Contact |
HELMUT D. LINK |
Correspondent |
WALDEMAR LINK GMBH & CO. KG |
BARKHAUSENWEG 10 |
HAMBURG,
DE
22339
|
|
Correspondent Contact |
Andre Von Malotki |
Regulation Number | 888.3510
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/26/2015 |
Decision Date | 05/09/2016 |
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
|
|
|