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510(k) K252997

HyperFlex® Bunion Correction System by Hyperflex Medical — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2025
Date Received
September 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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