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Succession AFN System

by Ortho Solutions UK, Ltd. 510(k)

Active United States

510(k) K250622

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250622 Date7 Aug 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HSB
FDA applicant
Ortho Solutions UK , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Succession AFN System is an orthopedic device with product code HSB. It is a Class 2 device cleared through the Traditional 510(k) pathway.

The device is manufactured by Ortho Solutions UK, Ltd. and has FDA 510(k) clearance. It is supplied with a product code of HSB and has a k number of K250622.

Other devices from Ortho Solutions UK, Ltd.

See all devices from Ortho Solutions UK, Ltd. →

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Succession AFN System used for?

    The Succession AFN System is an orthopedic device, but its specific use is not detailed in the provided information, however it has a product code of HSB and is classified as a Class 2 device.

  • Is the Succession AFN System supplied sterile?

    The provided information does not specify whether the Succession AFN System is supplied sterile or not.

  • What is the regulatory status of the Succession AFN System?

    The Succession AFN System has FDA 510(k) clearance, which means it has been cleared through the Traditional 510(k) pathway as a substantially equivalent device.