The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolve Radial Plate.
| Device ID | K033456 |
| 510k Number | K033456 |
| Device Name: | EVOLVE RADIAL PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Katie Logerot |
| Correspondent | Katie Logerot WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-30 |
| Decision Date | 2004-01-28 |
| Summary: | summary |