The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolution Unicondylar Knee System.
| Device ID | K100973 |
| 510k Number | K100973 |
| Device Name: | EVOLUTION UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Danielle Mueller |
| Correspondent | Danielle Mueller WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-08 |
| Decision Date | 2010-08-10 |
| Summary: | summary |