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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 the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) 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. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K201838.

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

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

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.

K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemK252600Pediatric Plating Platform I Small-MiniK251362PediFlex™ Flexible Nail SystemK243963Pediatric Plating Platform HipK250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurK241816VerteGlide Spinal Growth Guidance System

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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.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical TechnologiesK241014Biomet Kirschner Wires (K-Wires)Biomet, Inc.

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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