Synapse SD Drill Guide

  • Model / Serial
    Part Number SD389.477, Lot Number 6913900
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution: PA only. .
  • Product Description
    Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 || Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
  • Source
    USFDA