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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1010
In Commercial Distribution

  • 07640136270019 ()


  • External orthopaedic fixation system, single-use
BONE SCREW, EDX - 3.2Ø x 16mm
XNAV TECHNOLOGIES LLC
P010308
In Commercial Distribution

  • 00817421021442 ()
  • 00817421021435 ()
  • 00817421022739 ()
P010308

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 8mm
XNAV TECHNOLOGIES LLC
P010307
In Commercial Distribution

  • 00817421021428 ()
  • 00817421021411 ()
  • 00817421022722 ()
P010307

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 4mm
XNAV TECHNOLOGIES LLC
P010306
In Commercial Distribution

  • 00817421021404 ()
  • 00817421021398 ()
  • 00817421022715 ()
P010306

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 16mm
XNAV TECHNOLOGIES LLC
P010305
In Commercial Distribution

  • 00817421021381 ()
  • 00817421021374 ()
  • 00817421022708 ()
P010305

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 8mm
XNAV TECHNOLOGIES LLC
P010304
In Commercial Distribution

  • 00817421021367 ()
  • 00817421021350 ()
  • 00817421022692 ()
P010304

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 4mm
XNAV TECHNOLOGIES LLC
P010303
In Commercial Distribution

  • 00817421021343 ()
  • 00817421021336 ()
  • 00817421022685 ()
P010303

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
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