Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K201364 |
Device Name |
LINK TrabecuLink Femoral Cones |
Applicant |
Waldemar Link GmbH & Co. KG |
Ostsraße 4-10 |
Norderstedt,
DE
22844
|
|
Applicant Contact |
Stefanie Fuchs |
Correspondent |
LinkBio Corp. |
69 King Street |
Dover,
NJ
07801
|
|
Correspondent Contact |
Terry Powell |
Regulation Number | 888.3565
|
Classification Product Code |
|
Date Received | 05/22/2020 |
Decision Date | 07/17/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|