The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Variax Elbow System.
| Device ID | K101056 |
| 510k Number | K101056 |
| Device Name: | VARIAX ELBOW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Melissa Matarese |
| Correspondent | Melissa Matarese HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-15 |
| Decision Date | 2010-05-13 |
| Summary: | summary |