Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OrthoNext Platform System

K-Number: K242270 · 2024-12-19

ApplicantOrthofix Srl
Decision Date2024-12-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OrthoNext Platform System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242270. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoNext Platform System?

OrthoNext Platform System is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Orthofix Srl. The 510(k) number is K242270.

When did OrthoNext Platform System receive FDA 510(k) clearance?

OrthoNext Platform System received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242270.

Who is the listed applicant for OrthoNext Platform System?

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 OrthoNext Platform System?

The FDA product code for OrthoNext Platform System is QIH.

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® TAAK250112FitboneTM TrochantericK242861TrueLok ElevateK233867Fitbone TrochantericK232648RODEO Telescopic Nail

View all 24 devices →

Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, 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.

↑