The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prophecy Pre-operative Navigation Alignment Guides.
| Device ID | K103598 |
| 510k Number | K103598 |
| Device Name: | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Sarah Holtgrewe |
| Correspondent | Sarah Holtgrewe WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MBH |
| Subsequent Product Code | JWH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-08 |
| Decision Date | 2011-10-17 |
| Summary: | summary |