The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Evolution Revision Tibial Base, Evolution Revision Tibial Block Augment, Evolution Revision Modular Keels, Evolution Revision Stem Adapters (offset And Extension), Evolution Revision Cemented Stem Extensions, Canal Filling Stem Extensions.
| Device ID | K162026 |
| 510k Number | K162026 |
| Device Name: | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset And Extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MicroPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Byron Ledbetter |
| Correspondent | Byron Ledbetter MicroPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-03-01 |
| Summary: | summary |