The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Anchorage 2 Cp System.
Device ID | K151769 |
510k Number | K151769 |
Device Name: | Anchorage 2 CP System |
Classification | Plate, Fixation, Bone |
Applicant | STRYKER GMBH 325 CORPORATE DRIVE Mahwah, NJ 07430 |
Contact | Kurdea Lyon |
Correspondent | Kurdea Lyon 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 | 2015-06-30 |
Decision Date | 2015-10-27 |
Summary: | summary |