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Dyna Locking Trochanteric Nail, Model NG0820

by U&I Corp. 510(k)

Active United States

510(k) K093707

Overview

The Dyna Locking Trochanteric Nail, Model NG0820 is an intramedullary rod fixation device intended for the alignment, stabilization, and fixation of femoral fractures. It is designed for use in pertrochanteric, subtrochanteric, intertrochanteric, and comminuted fractures resulting from trauma or disease.

The device is supplied as a sterile, single-use implant and is indicated for implantation into the intramedullary canal and head of the femur. It received FDA 510(k) clearance (K093707) as a Class II medical device under product code HSB, with a traditional clearance pathway and a decision of substantially equivalent on June 23, 2010.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093707 Date23 Jun 2010ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Dyna Locking Trochanteric Nail, Model NG0820 used for?

    The Dyna Locking Trochanteric Nail, Model NG0820 is an intramedullary rod fixation device intended for the alignment, stabilization, and fixation of femoral fractures, specifically pertrochanteric, subtrochanteric, intertrochanteric, and comminuted fractures resulting from trauma or disease.

  • How is the Dyna Locking Trochanteric Nail, Model NG0820 supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is provided in a sterile condition and is intended for one-time implantation only; it is not designed for reuse after removal from the patient.

  • What regulatory pathway was used for the Dyna Locking Trochanteric Nail, Model NG0820 and what was the outcome?

    The device received FDA 510(k) clearance under the traditional pathway, with a decision of substantially equivalent on June 23, 2010, under K093707, and is classified as a Class II medical device under product code HSB.