The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Evolution Stemmed Cs Femur.
| Device ID | K182125 |
| 510k Number | K182125 |
| Device Name: | EVOLUTION Stemmed CS Femur |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Hunter Ethan Williams |
| Correspondent | Hunter Ethan Williams 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 | 2018-08-06 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684EFSRN8RR1 | K182125 | 000 |
| M684EFSRN3RR1 | K182125 | 000 |
| M684EFSRN4RL1 | K182125 | 000 |
| M684EFSRN4RR1 | K182125 | 000 |
| M684EFSRN5RL1 | K182125 | 000 |
| M684EFSRN5RR1 | K182125 | 000 |
| M684EFSRN6RL1 | K182125 | 000 |
| M684EFSRN6RR1 | K182125 | 000 |
| M684EFSRN7RL1 | K182125 | 000 |
| M684EFSRN7RR1 | K182125 | 000 |
| M684EFSRN8RL1 | K182125 | 000 |
| M684EFSRN3RL1 | K182125 | 000 |