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)

Succession™ AFN System

K-Number: K250622 · 2025-08-07

ApplicantOrtho Solutions UK , Ltd.
Decision Date2025-08-07
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Succession™ AFN System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions UK , Ltd.. It received FDA 510(k) clearance on 2025-08-07 under 510(k) number K250622. 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 Succession™ AFN System?

Succession™ AFN System is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is Ortho Solutions UK , Ltd.. The 510(k) number is K250622.

When did Succession™ AFN System receive FDA 510(k) clearance?

Succession™ AFN System received FDA 510(k) clearance on 2025-08-07, under 510(k) number K250622.

Who is the listed applicant for Succession™ AFN System?

The FDA 510(k) record lists Ortho Solutions UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Succession™ AFN System?

The FDA product code for Succession™ AFN System is HSB.

Other records listing Ortho Solutions UK , Ltd. 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.

K240212COGNiTiON™ Staple SystemK210658Volition Plating SystemK202764Ortho Solutions Plating SystemK163489OrthoSolutions 'System26' Bone Screws

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.

↑