Synthes 6.5 mm Cancellous Screws

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

Full name

Synthes (USA) 6.5 Mm Cancellous Screws

510(k) Number

K061621 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

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 are the Synthes 6.5 mm Cancellous Screws used for?

  These screws are indicated for orthopedic bone fixation procedures, including those involving the foot and ankle. They are designed as metallic fasteners to provide stability during surgical intervention.

• What materials and design features are available for these screws?

  The screws are manufactured from either stainless steel or titanium alloy. They feature a fully threaded shaft, a core diameter between 3.2 mm and 4.0 mm, and a flat head profile with rounded edges.

• How are these screws supplied and what sizes are offered?

  The screws are available in lengths ranging from 60 mm to 130 mm to accommodate different surgical requirements. They are supplied to the user in either sterile or non-sterile packaging.

• What is the regulatory status of this device?

  The Synthes 6.5 mm Cancellous Screws have received FDA 510k clearance, which indicates they have been found substantially equivalent to legally marketed predicate devices.