510(k) K201210

The Micro Screw System, Micro Screw System Basic by Hager& Meisinger GmbH — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2021
Date Received
May 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type