The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Facial Id Plating System.
Device ID | K193143 |
510k Number | K193143 |
Device Name: | Stryker Facial ID Plating System |
Classification | Plate, Bone |
Applicant | Stryker 750 Trade Centre Way- Suite 200 Portage, MI 49002 |
Contact | Zainab Amini |
Correspondent | Zainab Amini Stryker 750 Trade Centre Way- Suite 200 Portage, MI 49002 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-13 |
Decision Date | 2020-03-26 |