510(k) K200113

LINK TrabecuLink Tibial Cones by Waldemar Link GmbH & Co. KG — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2020
Date Received
January 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type