Synthes Small Cobination Clamp-MR Safe

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

510(k) Number

K031724 ↗

FDA Product Code

KTT

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 Synthes Small Combination Clamp-MR Safe used for?

  The Synthes Small Combination Clamp-MR Safe is a mechanical component of an external fixation frame system designed to stabilize bone fractures in the hand, wrist, mandible, and foot. It connects 4.0 mm carbon fiber rods, various diameter Schanz screws, and 2.5 mm K-wires for orthopedic trauma treatment.

• Is the Synthes Small Combination Clamp-MR Safe designed for single-use or reuse?

  The device is supplied as part of an external fixation frame system and is designed to be compatible with various components. However, the device data does not specify whether it is intended for single-use or multiple uses.

• What regulatory approvals does the Synthes Small Combination Clamp-MR Safe have?

  The Synthes Small Combination Clamp-MR Safe received FDA 510(k) clearance with K-number K031724 on July 14, 2003. It is specifically designed for use in the MR environment and is intended for orthopedic trauma treatment in clinical settings.

• What components is the Synthes Small Combination Clamp-MR Safe compatible with?

  The device is designed to connect 4.0 mm carbon fiber rods, various diameter Schanz screws (4.0/4.0, 4.0/3.0, 4.0/2.5 mm), and 2.5 mm K-wires as part of an external fixation frame system for bone fracture stabilization.