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FDA 510(k)

FitboneTM Trochanteric

K-Number: K250112 · 2025-04-10

ApplicantOrthofix Srl
Decision Date2025-04-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FitboneTM Trochanteric is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250112. 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 FitboneTM Trochanteric?

FitboneTM Trochanteric is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Orthofix Srl. The 510(k) number is K250112.

When did FitboneTM Trochanteric receive FDA 510(k) clearance?

FitboneTM Trochanteric received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250112.

Who is the listed applicant for FitboneTM Trochanteric?

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

What is the FDA product code for FitboneTM Trochanteric?

The FDA product code for FitboneTM Trochanteric is HSB.

Other records listing Orthofix Srl 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.

K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMK253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAK242270OrthoNext Platform SystemK242861TrueLok ElevateK233867Fitbone TrochantericK232648RODEO Telescopic Nail

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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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