510(k) K231599

Stryker MP, Mandible, HMMF and MMF AXS Screws by Stryker Leibinger GmbH & Co KG — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2023
Date Received
June 1, 2023
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