Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
|
510(k) Number |
K171273 |
Device Name |
LINK® BiMobile(TM) Dual Mobility System |
Applicant |
Waldemar Link Gmbh & Co. KG |
Barkhausenweg 10 |
Hamburg,
DE
22339
|
|
Applicant Contact |
Stefanie Reimers |
Correspondent |
Waldemar Link Gmbh & Co. KG |
Barkhausenweg 10 |
Hamburg,
DE
22339
|
|
Correspondent Contact |
Henrik Kroh |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/01/2017 |
Decision Date | 01/19/2018 |
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
|
|
|