510(k) K143106

VEGA Knee System by Aesculap Implant Systems, LLC — Product Code JWH

K143106 is an FDA 510(k) premarket notification submitted by Aesculap Implant Systems, LLC for the device "VEGA Knee System". The FDA issued a decision of Substantially Equivalent on November 21, 2014. 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. Aesculap Implant Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2014
Date Received
October 29, 2014
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