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FDA 510(k)

PediFlex Flexible Nail System

K-Number: K201838 · 2021-01-29

ApplicantOrthoPediatrics Corp.
Decision Date2021-01-29
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 2021-01-29 under approval number K201838. 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 2021-01-29. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K201838.

When was PediFlex Flexible Nail System approved by the FDA?

PediFlex Flexible Nail System received FDA 510(k) clearance on 2021-01-29, under approval number K201838.

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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