Synthes Schuhli Implant System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K980944 ↗

FDA Product Code

HTN

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What is the purpose of the Synthes Schuhli Implant System?

  The Schuhli Implant System is designed to lock screws to plates in orthopedic applications, providing stability during long bone and small bone procedures. It functions as part of a comprehensive orthopedic fixation system.

• How is the Schuhli Implant System supplied and what is its regulatory status?

  The device is supplied as part of a system by Synthes (Usa). It is regulated under FDA 510(k) clearance with product code HTN and classified as a Class 2 device under regulation 888.3030 for Washer, Bolt Nut in orthopedic medical specialty.

• Is the Schuhli Implant System reusable or single-use?

  The device information does not specify whether the Schuhli Implant System is designed for single-use or reuse. For proper handling and reuse instructions, clinicians should refer to the product documentation provided by the manufacturer.

• What sizes and models of the Schuhli Implant System are available?

  The device data does not provide specific information about available sizes or models of the Schuhli Implant System. Clinicians should consult the manufacturer's catalog or product documentation for detailed specifications regarding available configurations.

• What are the storage requirements for the Schuhli Implant System?

  The device data does not specify storage requirements for the Schuhli Implant System. Proper storage conditions should be determined based on manufacturer guidelines to maintain device integrity and functionality before use in orthopedic procedures.