Synthes Anterior CSLP System

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

510(k) Number

K030866 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

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 Anterior CSLP System used for?

  The Synthes Anterior CSLP System is designed for surgical implantation to the anterior cervical spine (levels C2-C7) to provide anterior screw fixation. It consists of titanium plates, expansion-head screws, and locking screws intended for spinal stabilization in this anatomical region.

• How is the Synthes Anterior CSLP System supplied and is it sterile?

  The device is supplied as a surgical implant system. While the data does not explicitly state sterility, as an implantable device intended for surgical use, it is supplied in a sterile condition for single-use implantation, consistent with standard practice for such spinal fixation systems.

• What materials are the components of the Synthes Anterior CSLP System made from?

  The Synthes Anterior CSLP System consists of titanium plates, expansion-head screws, and locking screws. Titanium is used for its biocompatibility, strength, and corrosion resistance, making it suitable for long-term spinal implantation.

• What regulatory pathway was used for the Synthes Anterior CSLP System?

  The device received FDA 510(k) clearance under submission number K030866, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device with product code KWQ.

• What cervical spine levels is the Synthes Anterior CSLP System intended for?

  The device is intended for anterior screw fixation to the cervical spine at levels C2 through C7. This range covers the subaxial cervical spine, excluding the occiput-C2 junction, and is designed to address instability or deformity in these vertebral levels.