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FDA 510(k)

Pediatric Nailing PlatformFemur

K-Number: K190321 · 2019-10-09

ApplicantOrthoPediatrics Corp.
Decision Date2019-10-09
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pediatric Nailing PlatformFemur is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K190321. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pediatric Nailing PlatformFemur?

Pediatric Nailing PlatformFemur is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K190321.

When did Pediatric Nailing PlatformFemur receive FDA 510(k) clearance?

Pediatric Nailing PlatformFemur received FDA 510(k) clearance on 2019-10-09, under 510(k) number K190321.

Who is the listed applicant for Pediatric Nailing PlatformFemur?

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 Pediatric Nailing PlatformFemur?

The FDA product code for Pediatric Nailing PlatformFemur is HSB.

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: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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