Stryker SonicPin System

Pin, Fixation, Smooth

Stryker Trauma Gmbh

The following data is part of a premarket notification filed by Stryker Trauma Gmbh with the FDA for Stryker Sonicpin System.

Pre-market Notification Details

Device IDK170418
510k NumberK170418
Device Name:Stryker SonicPin System
ClassificationPin, Fixation, Smooth
Applicant Stryker Trauma Gmbh Prof-Kuentscher-Str. 1-5 Schoenkirchen,  DE 24232
ContactHeike Gustke
CorrespondentHeike Gustke
Stryker Trauma Gmbh Prof-Kuentscher-Str. 1-5 Schoenkirchen,  DE 24232
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-13
Decision Date2017-06-20
Summary:summary

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