510(k) K203779

Symmetric Total Knee System by Signal Medical Corporation — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2021
Date Received
December 28, 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