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510(k) K251680

Biosteon® Screw by Biocomposites, Ltd. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2026
Date Received
May 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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