Synthes Mandible External Fixator

  • Model / Serial
    All lots of part nos.:  04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    The Synthes Mandible External Fixator; all lots of part nos.: || 04.305.003 || 04.305.004 || 04.305.005 || 04.305.010 || 04.305.011 || 04.305.012 || 03.305.006 || 04.305.100 || 04.305.101 || 04.305.102 || 04.305.103 || 04.305.128 || 04.305.130 || 04.305.134 || 04.305.138 || 04.305.140 || 04.305.142 || 03.305.105 || 03.305.500 || 03.305.500S || Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
  • Manufacturer
  • 1 Event

Manufacturer

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