The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prophecy Preoperative Navigation Alignment System.
| Device ID | K202815 |
| 510k Number | K202815 |
| Device Name: | PROPHECY Preoperative Navigation Alignment System |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Wright Medical Technology, Inc. 10801 Nesbitt Ave S Bloomington, MN 55437 |
| Contact | Paxia Her |
| Correspondent | Paxia Her Wright Medical Technology, Inc. 10801 Nesbitt Ave S Bloomington, MN 55437 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-24 |
| Decision Date | 2021-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797102353 | K202815 | 000 |