The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Invision Total Ankle Revision System.
| Device ID | K180730 |
| 510k Number | K180730 |
| Device Name: | INVISION Total Ankle Revision System |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Alayne Melancon |
| Correspondent | Alayne Melancon Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-20 |
| Decision Date | 2018-07-11 |
| Summary: | summary |