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510(k) K241010

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors by Depuy Mitek — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2024
Date Received
April 12, 2024
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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