The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prophecy Invision Pre-operative Navigation System.
| Device ID | K170968 |
| 510k Number | K170968 |
| Device Name: | PROPHECY INVISION Pre-operative Navigation 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 | 2017-03-31 |
| Decision Date | 2017-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420194725 | K170968 | 000 |