The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Variax Distal Radius Torx Screws.
| Device ID | K080667 |
| 510k Number | K080667 |
| Device Name: | VARIAX DISTAL RADIUS TORX SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Danielle Hillman |
| Correspondent | Danielle Hillman HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-03-19 |
| Summary: | summary |