510(k) K201561

Membrane Screws and Membrane Tacks by Neoss Limited — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2020
Date Received
June 10, 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