Synthes (U.S.A.) Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System

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

510(k) Number

K951626 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

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 is the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System used for?

  It is intended for use as a posterior pedicle screw fixation system in spinal surgery, allowing surgeons to build a customized implant system using screws, rods, and other components to match patient anatomy.

• How is the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System supplied?

  The system is supplied as a fixation system for spinal surgery, composed of multiple components made from various materials, though the data does not specify whether it is sterile, single-use, or reusable.

• What regulatory pathway was used for the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System?

  It received FDA 510(k) clearance under K951626, classified as substantially equivalent for some indications and reviewed by the Orthopedic advisory committee.