The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Anchorage Bone Plating System.
Device ID | K172148 |
510k Number | K172148 |
Device Name: | Anchorage Bone Plating System |
Classification | Plate, Fixation, Bone |
Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Jackie Perri |
Correspondent | Jackie Perri Stryker GmbH 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 | 2017-07-17 |
Decision Date | 2018-03-19 |
Summary: | summary |