The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolve Ceramic Radial Head Implant.
| Device ID | K030384 |
| 510k Number | K030384 |
| Device Name: | EVOLVE CERAMIC RADIAL HEAD IMPLANT |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Jeanine H Redden |
| Correspondent | Jeanine H Redden WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420133892 | K030384 | 000 |
| 00840420133762 | K030384 | 000 |
| 00840420133779 | K030384 | 000 |
| 00840420133786 | K030384 | 000 |
| 00840420133793 | K030384 | 000 |
| 00840420133809 | K030384 | 000 |
| 00840420133816 | K030384 | 000 |
| 00840420133823 | K030384 | 000 |
| 00840420133830 | K030384 | 000 |
| 00840420133847 | K030384 | 000 |
| 00840420133854 | K030384 | 000 |
| 00840420133861 | K030384 | 000 |
| 00840420133878 | K030384 | 000 |
| 00840420133885 | K030384 | 000 |
| 00840420133755 | K030384 | 000 |