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FDA 510(k)

Pediatric Nailing Platform Tibia

K-Number: K231266 · 2023-08-21

ApplicantOrthoPediatrics Corp.
Decision Date2023-08-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pediatric Nailing Platform Tibia is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K231266. 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 Platform Tibia?

Pediatric Nailing Platform Tibia is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K231266.

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

Pediatric Nailing Platform Tibia received FDA 510(k) clearance on 2023-08-21, under 510(k) number K231266.

Who is the listed applicant for Pediatric Nailing Platform Tibia?

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 Platform Tibia?

The FDA product code for Pediatric Nailing Platform Tibia 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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