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FDA 510(k)

PEDINAIL INTRAMEDULLARY NAILING SYSTEM

K-Number: K083726 · 2009-03-11

ApplicantOrthoPediatrics Corp.
Decision Date2009-03-11
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEDINAIL INTRAMEDULLARY NAILING 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 2009-03-11 under 510(k) number K083726. 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 PEDINAIL INTRAMEDULLARY NAILING SYSTEM?

PEDINAIL INTRAMEDULLARY NAILING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-11. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K083726.

When did PEDINAIL INTRAMEDULLARY NAILING SYSTEM receive FDA 510(k) clearance?

PEDINAIL INTRAMEDULLARY NAILING SYSTEM received FDA 510(k) clearance on 2009-03-11, under 510(k) number K083726.

Who is the listed applicant for PEDINAIL INTRAMEDULLARY NAILING 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 PEDINAIL INTRAMEDULLARY NAILING SYSTEM?

The FDA product code for PEDINAIL INTRAMEDULLARY NAILING SYSTEM is HSB.

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Other records listing OrthoPediatrics Corp. as applicant

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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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., 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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