The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolution Mp Adaptive Cs Insert.
| Device ID | K113325 |
| 510k Number | K113325 |
| Device Name: | EVOLUTION MP ADAPTIVE CS INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-10 |
| Decision Date | 2011-12-09 |
| Summary: | summary |