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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 Size Type Device Class Implantable

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12/14 Taper HNSS 28/+3.5 Modular Femoral Head
MAXX ORTHOPEDICS, INC.
MO-HDAM-28/35+
In Commercial Distribution

  • 00810008120897 ()


  • Metal-on-polyethylene total hip prosthesis
12/14 Taper HNSS 28/-3.5 Modular Femoral Head
MAXX ORTHOPEDICS, INC.
MO-HDAM-28/35-
In Commercial Distribution

  • 00810008120880 ()


  • Metal-on-polyethylene total hip prosthesis
12/14 Taper HNSS 28/+0 Modular Femoral Head
MAXX ORTHOPEDICS, INC.
MO-HDAM-28/00
In Commercial Distribution

  • 00810008120873 ()


  • Metal-on-polyethylene total hip prosthesis
12/14 Taper HNSS 22/+3.5 Modular Femoral Head
MAXX ORTHOPEDICS, INC.
MO-HDAM-22/35+
In Commercial Distribution

  • 00810008120866 ()


  • Metal-on-polyethylene total hip prosthesis
12/14 Taper HNSS 22/+0 Modular Femoral Head
MAXX ORTHOPEDICS, INC.
MO-HDAM-22/00
In Commercial Distribution

  • 00810008120859 ()


  • Metal-on-polyethylene total hip prosthesis
The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
Wenzel Spine, Inc.
CIC2-10-12-00
In Commercial Distribution

  • 00813210020856 ()

  • Length: 12 Millimeter
  • Height: 10 Millimeter


  • Metallic spinal interbody fusion cage
The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
Wenzel Spine, Inc.
CIC2-09-12-00
In Commercial Distribution

  • 00813210020849 ()

  • Length: 12 Millimeter
  • Height: 9.0 Millimeter


  • Metallic spinal interbody fusion cage
The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
Wenzel Spine, Inc.
CIC2-08-12-00
In Commercial Distribution

  • 00813210020832 ()

  • Length: 12 Millimeter
  • Height: 8.0 Millimeter


  • Metallic spinal interbody fusion cage
The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
Wenzel Spine, Inc.
CIC1-9.0-12-00
In Commercial Distribution

  • 00813210020061 ()

  • Outer Diameter: 9.0 Millimeter
  • Length: 12 Millimeter


  • Metallic spinal interbody fusion cage
The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
Wenzel Spine, Inc.
CIC1-7.5-12-00
In Commercial Distribution

  • 00813210020054 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 12 Millimeter


  • Metallic spinal interbody fusion cage
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