Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System

Screw, Fixation, Bone

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Asnis Iii Cannulated Screw System, Asnis Pro Cannulated Screw System.

Pre-market Notification Details

Device IDK220319
510k NumberK220319
Device Name:Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
ClassificationScrew, Fixation, Bone
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactDanielle Jannuzzi Madureira
CorrespondentDanielle Jannuzzi Madureira
Stryker GmbH Dr. Homer Stryker Strasse, 1 CH-2545 Selzach,  CH
Product CodeHWC  
Subsequent Product CodeHTN
Subsequent Product CodeOUR
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-03
Decision Date2022-06-10

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.