The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Mesh.
Device ID | K170773 |
510k Number | K170773 |
Device Name: | Stryker Universal Mesh |
Classification | Plate, Bone |
Applicant | Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
Contact | Gregory Gohl |
Correspondent | Gregory Gohl Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-14 |
Decision Date | 2017-11-08 |
Summary: | summary |