The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prophecy Inbone Pre-operative Navigation Alignment Guides.
| Device ID | K110360 |
| 510k Number | K110360 |
| Device Name: | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, 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 | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-08 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797052078 | K110360 | 000 |
| 00889797052061 | K110360 | 000 |
| 00889797052054 | K110360 | 000 |
| 00889797052047 | K110360 | 000 |
| 00889797052030 | K110360 | 000 |
| 00889797057110 | K110360 | 000 |