Stryker SonicPin System
510(k) K170418
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170418 | Date20 Jun 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Stryker Trauma AG
Questions
AI-generated answers, 23 Sep 2026
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.