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510(k) K251362

PediFlex™ Flexible Nail System by OrthoPediatrics Corp. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2025
Date Received
May 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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Other clearances for product code HTY

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  • K231905 — Electro-Spec Steri-Caps (August 14, 2023)
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