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FDA 510(k)

PediFlex™ Flexible Nail System

K-Number: K251362 · 2025-06-24

ApplicantOrthoPediatrics Corp.
Decision Date2025-06-24
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PediFlex™ Flexible Nail System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-06-24 under approval number K251362. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PediFlex™ Flexible Nail System?

PediFlex™ Flexible Nail System is a medical device that received FDA 510(k) clearance on 2025-06-24. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K251362.

When was PediFlex™ Flexible Nail System approved by the FDA?

PediFlex™ Flexible Nail System received FDA 510(k) clearance on 2025-06-24, under approval number K251362.

What company makes PediFlex™ Flexible Nail System?

PediFlex™ Flexible Nail System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for PediFlex™ Flexible Nail System?

The FDA product code for PediFlex™ Flexible Nail System is HTY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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