Synthes Anterior Spinal Plate

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

Full name

Synthes(U.S.A.) Anterior Spinal Plate

510(k) Number

K925351 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SN

• 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 types of spinal surgeries is this plate designed to support, and how does it provide stability?

  The Synthes Anterior Spinal Plate is designed for internal fixation of the spine during orthopedic procedures, specifically to stabilize the vertebral column. It achieves this by making direct contact with vertebral bodies, maintaining alignment, and promoting spinal fusion. The titanium construction ensures durability and compatibility with the body, while its anterior placement helps secure the spine during recovery.

• Is this device reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

  This device is explicitly intended for single-use only and is supplied sterile. To preserve sterility before surgery, it must be stored and handled according to standard sterile medical device protocols—typically in a sealed, unopened packaging until immediately before use, following manufacturer guidelines to prevent contamination.

• What materials is the plate made from, and why does that matter for spinal surgery?

  The Synthes Anterior Spinal Plate is constructed from titanium, a material chosen for its biocompatibility, strength, and resistance to corrosion. In spinal surgery, these properties reduce the risk of adverse reactions, ensure long-term stability, and support the body’s natural healing process without degrading over time.

• How is this device regulated in the U.S., and what does the product code (KWQ) signify?

  This device is regulated under the FDA’s 510(k) clearance pathway, specifically through the Traditional 510(k) route with clearance number K925351. The product code KWQ categorizes it under orthopedic spinal fixation hardware, indicating it falls within the orthopedic specialty and adheres to FDA standards for spinal orthoses and fixation devices.