The following data is part of a premarket notification filed by Howmedica Osteonics Corp Dba Stryker Orthopaedics with the FDA for Aiming Blocks For Variax Distal Radius Plates.
| Device ID | K112455 |
| 510k Number | K112455 |
| Device Name: | AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Stephanie Fitts |
| Correspondent | Stephanie Fitts 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-25 |
| Decision Date | 2011-09-22 |
| Summary: | summary |