510(k) K152631

MPO Total Knee Systems MR Labeling by Microport Orthopedics, Inc. — Product Code HRY

K152631 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "MPO Total Knee Systems MR Labeling". The FDA issued a decision of Substantially Equivalent on March 23, 2016. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Microport Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2016
Date Received
September 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type