The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prophecy Invision Preoperative Navigation Alignment System.
| Device ID | K162795 |
| 510k Number | K162795 |
| Device Name: | PROPHECY INVISION Preoperative Navigation Alignment System |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 37117 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 37117 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-04 |
| Decision Date | 2017-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420185662 | K162795 | 000 |