The following data is part of a premarket notification filed by Stryker Trauma Gmbh with the FDA for Stryker Sonicpin System.
Device ID | K170418 |
510k Number | K170418 |
Device Name: | Stryker SonicPin System |
Classification | Pin, Fixation, Smooth |
Applicant | Stryker Trauma Gmbh Prof-Kuentscher-Str. 1-5 Schoenkirchen, DE 24232 |
Contact | Heike Gustke |
Correspondent | Heike Gustke Stryker Trauma Gmbh Prof-Kuentscher-Str. 1-5 Schoenkirchen, DE 24232 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-13 |
Decision Date | 2017-06-20 |
Summary: | summary |