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Stryker SonicPin System

by Stryker Trauma GmbH

510(k) K170418

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 NumberK170418 Date20 Jun 2017ClearedStatusActive

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  • Withdrawn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
HTY
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Stryker SonicPin System is an orthopedic device used for fracture fixation. It is designed to provide stabilization for bone fractures through the use of specialized pins.

The system is supplied by Stryker Trauma GmbH and is authorized under FDA 510K clearance. It is intended for single-use and should be stored according to the manufacturer's instructions. The device is available in various sizes as specified by the model numbers.

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Questions

AI-generated answers, 23 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 Stryker SonicPin System used for?

    The Stryker SonicPin System is an orthopedic device designed for fracture fixation, providing stabilization for bone fractures through the use of specialized pins.

  • Is the SonicPin System reusable or single-use?

    The SonicPin System is intended for single-use only and should not be reused on multiple patients. Proper disposal after use is required according to medical waste protocols.

  • What sizes and models are available for the SonicPin System?

    The SonicPin System is available in various sizes as specified by different model numbers. The specific sizes and model options should be selected based on the clinical requirements of the fracture being treated.

  • How should the SonicPin System be stored?

    The SonicPin System should be stored according to the manufacturer's instructions to maintain its integrity and functionality until use. Proper storage conditions help ensure the device remains safe and effective for its intended purpose.