The following data is part of a premarket notification filed by Howmedica Osteonics Corp Dba Stryker Orthopaedics with the FDA for Axsos Distal Lateral Femur Ts Long Plates.
Device ID | K122308 |
510k Number | K122308 |
Device Name: | AXSOS DISTAL LATERAL FEMUR TS LONG PLATES |
Classification | Plate, Fixation, Bone |
Applicant | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Stephanie M Fitts |
Correspondent | Stephanie M 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 | 2012-08-01 |
Decision Date | 2012-10-01 |
Summary: | summary |