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 | K171067 |
| 510k Number | K171067 |
| 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 | Val Myles |
| Correspondent | Val Myles 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 | 2017-04-10 |
| Decision Date | 2017-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420194534 | K171067 | 000 |
| 00840420194282 | K171067 | 000 |
| 00840420194275 | K171067 | 000 |
| 00840420194268 | K171067 | 000 |
| 00840420194251 | K171067 | 000 |
| 00840420193964 | K171067 | 000 |
| 00840420193957 | K171067 | 000 |
| 00840420193940 | K171067 | 000 |
| 00840420193766 | K171067 | 000 |
| 00840420194299 | K171067 | 000 |
| 00840420194398 | K171067 | 000 |
| 00840420194527 | K171067 | 000 |
| 00840420194510 | K171067 | 000 |
| 00840420194503 | K171067 | 000 |
| 00840420194497 | K171067 | 000 |
| 00840420194435 | K171067 | 000 |
| 00840420194428 | K171067 | 000 |
| 00840420194411 | K171067 | 000 |
| 00840420194404 | K171067 | 000 |
| 00840420193759 | K171067 | 000 |