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510(k) K243190

USTOMED Bone Fixation/Bone Augmentation Systems - PIN by Ustomed Instrumente Ulrich Storz GmbH & Co. KG — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
September 30, 2024
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

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