The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prophecy Infinity Preoperative Navigation Alignment Guides.
| Device ID | K131283 |
| 510k Number | K131283 |
| Device Name: | PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Danielle Mueller |
| Correspondent | Danielle Mueller WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797057134 | K131283 | 000 |
| 00889797103374 | K131283 | 000 |
| 00889797102438 | K131283 | 000 |
| 00889797102421 | K131283 | 000 |
| 00889797102414 | K131283 | 000 |
| 00889797102407 | K131283 | 000 |
| 00889797102391 | K131283 | 000 |