510(k) K211938

Physica LMC Knee System by Limacorporate — Product Code JWH

K211938 is an FDA 510(k) premarket notification submitted by Limacorporate for the device "Physica LMC Knee System". The FDA issued a decision of Substantially Equivalent on July 13, 2021. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Limacorporate has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2021
Date Received
June 23, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type