The following data is part of a premarket notification filed by Howmedica Osteonics Corp Dba Stryker Orthopaedics with the FDA for Variax Superior And Anterior, Lateral And Midshaft Clavicle Plates Variax Aiming Blocks & Joystick.
| Device ID | K113760 |
| 510k Number | K113760 |
| Device Name: | VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Valerie Giambanco |
| Correspondent | Valerie Giambanco HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 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 | 2011-12-21 |
| Decision Date | 2012-04-25 |
| Summary: | summary |