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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 the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-06-24 under 510(k) 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. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K251362.

When did PediFlex™ Flexible Nail System receive FDA 510(k) clearance?

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

Who is the listed applicant for PediFlex™ Flexible Nail System?

The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing OrthoPediatrics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K250646Impact PEEK Union Nail SystemNvision Biomedical TechnologiesK241014Biomet Kirschner Wires (K-Wires)Biomet, Inc.K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailOSSIO , Ltd.

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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