The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Orthofix Volar Distal Radial Plate.
| Device ID | K042766 |
| 510k Number | K042766 |
| Device Name: | ORTHOFIX VOLAR DISTAL RADIAL PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOFIX, INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Contact | Nicolle L Ferris |
| Correspondent | Nicolle L Ferris ORTHOFIX, INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-05 |
| Decision Date | 2004-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242517009 | K042766 | 000 |
| 18054242516460 | K042766 | 000 |
| 18054242516361 | K042766 | 000 |
| 18054242516347 | K042766 | 000 |
| 18054242516217 | K042766 | 000 |
| 18054242516200 | K042766 | 000 |
| 18054242516194 | K042766 | 000 |
| 18054242516187 | K042766 | 000 |
| 18054242516170 | K042766 | 000 |
| 18054242516156 | K042766 | 000 |
| 18054242516149 | K042766 | 000 |
| 18054242516125 | K042766 | 000 |
| 18054242516118 | K042766 | 000 |
| 18054242516477 | K042766 | 000 |
| 18054242516484 | K042766 | 000 |
| 18054242516545 | K042766 | 000 |
| 18054242516996 | K042766 | 000 |
| 18054242516989 | K042766 | 000 |
| 18054242516972 | K042766 | 000 |
| 18054242516965 | K042766 | 000 |
| 18054242516958 | K042766 | 000 |
| 18054242516873 | K042766 | 000 |
| 18054242516866 | K042766 | 000 |
| 18054242516859 | K042766 | 000 |
| 18054242516842 | K042766 | 000 |
| 18054242516835 | K042766 | 000 |
| 18054242516828 | K042766 | 000 |
| 18054242516705 | K042766 | 000 |
| 18054242516033 | K042766 | 000 |