The following data is part of a premarket notification filed by Mircoport Orthopedics, Inc. with the FDA for Evolution Nitrx Medial-pivot Knee.
| Device ID | K182251 |
| 510k Number | K182251 |
| Device Name: | EVOLUTION NitrX Medial-Pivot Knee |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MircoPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Byron Ledbetter |
| Correspondent | Ryan Ross MircoPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | JWH |
| Subsequent Product Code | HRY |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2019-05-16 |
| Summary: | summary |