The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Mpo Total Knee Systems Mr Labeling.
| Device ID | K152631 |
| 510k Number | K152631 |
| Device Name: | MPO Total Knee Systems MR Labeling |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD Arlington, TN 38002 |
| Contact | Usman Rashid |
| Correspondent | Usman Rashid MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD Arlington, TN 38002 |
| Product Code | HRY |
| Subsequent Product Code | JWH |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2016-03-23 |
| Summary: | summary |