Synthes Spherical Washers

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Synthes (USA) Spherical Washers

510(k) Number

K052483 ↗

FDA Product Code

NDG

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 are the Synthes Spherical Washers used for in orthopedic procedures?

  The Synthes Spherical Washers are metallic, non-spinal orthopedic fixation components designed to distribute load and secure implants during surgical procedures. They are paired with bolts and nuts to ensure stable fixation in bone, helping to maintain proper alignment and support during the healing process.

• Are these washers reusable or single-use?

  The Synthes Spherical Washers are supplied as reusable metallic components. Unlike single-use devices, these washers are intended for repeated use in clinical settings, provided they meet manufacturer guidelines for cleaning, sterilization, and maintenance.

• What regulatory pathway does this device follow?

  The Synthes Spherical Washers are regulated under the FDA 510(k) clearance process, specifically with clearance number K052483. They fall under Class II devices for orthopedic use, adhering to Special Controls outlined in regulation 888.3030, and are classified under product code NDG.

• What sizes or models of Synthes Spherical Washers are available?

  The Synthes Spherical Washers come in multiple sizes and models, as indicated by the FEI numbers listed in the regulatory records: 3001236812, 3038503932, 1000306431, and others. These variations allow for compatibility with different orthopedic implants and fixation systems.

• Do these washers require any special storage or handling?

  While the provided data does not specify sterility requirements, as reusable metallic components, these washers must be stored in a clean, dry environment to prevent contamination. Proper cleaning and maintenance protocols should be followed to ensure their longevity and functionality for repeated use in surgical settings.