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510(k) K252946

BioBrace® Extra-Articular Ligament Augmentation Kit by Conmed Corporation — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2025
Date Received
September 15, 2025
Clearance Type
Special
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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