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Revolution Femoral Intramedullary Nail System, Model DGOOXX

by Dgimed Ortho, Inc.

510(k) K091309

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091309 Date5 Nov 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HSB
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 Revolution Femoral Intramedullary Nail System is an orthopedic device used for intramedullary nailing procedures. It is designed for treating midline femoral fractures, femoral fractures in multiple trauma patients, fractures in morbidly obese patients, and fractures in osteoporotic bone or malunions and nonunions.

The system is supplied as a single-use device and is not MRI safe. It is authorized under FDA 510K clearance with product code HSB and K number K091309. The device is manufactured by Dgimed Ortho, Inc. and is stored according to the manufacturer's instructions.

Other devices from Dgimed Ortho, Inc.

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 Revolution Femoral Intramedullary Nail System used for?

    The Revolution Femoral Intramedullary Nail System is designed for treating midline femoral fractures, femoral fractures in multiple trauma patients, fractures in morbidly obese patients, and fractures in osteoporotic bone or malunions and nonunions.

  • Is the Revolution Femoral Intramedullary Nail System reusable or single-use?

    The system is supplied as a single-use device and is not MRI safe. It should be used only once according to the manufacturer's instructions.

  • What is the regulatory status of the Revolution Femoral Intramedullary Nail System?

    The device is authorized under FDA 510K clearance with product code HSB and K number K091309. It was cleared through the traditional pathway and deemed substantially equivalent.

  • How should the Revolution Femoral Intramedullary Nail System be stored?

    The device should be stored according to the manufacturer's instructions. Specific storage conditions are not detailed in the provided information.