Modification to the Synthes (USA) Universal Spinal Hook, Rod, and and Sacral Screw Fixation System in 316l Stainless Ste

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

510(k) Number

K963357 ↗

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) →