The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Evolution Revision Cck System.
| Device ID | K171389 |
| 510k Number | K171389 |
| Device Name: | EVOLUTION Revision CCK System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Matt Paul |
| Correspondent | Matt Paul 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 | 2017-05-11 |
| Decision Date | 2017-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684EFCCN5RL1 | K171389 | 000 |
| M684E11010061 | K171389 | 000 |
| M684E12001171 | K171389 | 000 |
| M684E50010111 | K171389 | 000 |
| M684E50031041 | K171389 | 000 |
| M684E50031081 | K171389 | 000 |
| M684E50031121 | K171389 | 000 |
| M684E50041051 | K171389 | 000 |
| M684E50041101 | K171389 | 000 |
| M684EFCCN3RR1 | K171389 | 000 |
| 00192629159815 | K171389 | 000 |