The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Locked Plating System.
Device ID | K050512 |
510k Number | K050512 |
Device Name: | STRYKER LOCKED PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Vivian Kelly |
Correspondent | Vivian Kelly 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 | 2005-03-01 |
Decision Date | 2005-03-21 |
Summary: | summary |