The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Evolution Mp Revision Femur, Evolution Femoral Augments.
| Device ID | K142550 |
| 510k Number | K142550 |
| Device Name: | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Contact | Caroline Fryar |
| Correspondent | Caroline Fryar MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD 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 | 2014-09-10 |
| Decision Date | 2014-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684EFXSNP7R1 | K142550 | 000 |
| M684EFXPNP7L1 | K142550 | 000 |
| M684EFXPNP6R1 | K142550 | 000 |
| M684EFXPNP6L1 | K142550 | 000 |
| M684EFXPNP5R1 | K142550 | 000 |
| M684EFXPNP5L1 | K142550 | 000 |
| M684EFXPNP4R1 | K142550 | 000 |
| M684EFXPNP4L1 | K142550 | 000 |
| M684EFXPNP3R1 | K142550 | 000 |
| M684EFXPNP7R1 | K142550 | 000 |
| M684EFXSNP3L1 | K142550 | 000 |
| M684EFXSNP7L1 | K142550 | 000 |
| M684EFXSNP6R1 | K142550 | 000 |
| M684EFXSNP6L1 | K142550 | 000 |
| M684EFXSNP5R1 | K142550 | 000 |
| M684EFXSNP5L1 | K142550 | 000 |
| M684EFXSNP4R1 | K142550 | 000 |
| M684EFXSNP4L1 | K142550 | 000 |
| M684EFXSNP3R1 | K142550 | 000 |
| M684EFXPNP3L1 | K142550 | 000 |