The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Variax Distal Fibula Plate.
| Device ID | K081284 |
| 510k Number | K081284 |
| Device Name: | VARIAX DISTAL FIBULA PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Andrea M Dwyer |
| Correspondent | Andrea M Dwyer HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-06 |
| Decision Date | 2008-07-18 |
| Summary: | summary |