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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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Valeo II PL 11x25 0°, 9mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555123001009 ()

  • Length: 11 Millimeter
  • Outer Diameter: 9 Millimeter
  • Width: 25 Millimeter
12.300.1009

  • Ceramic spinal interbody fusion cage
Valeo II PL 11x25 0°, 8mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555123001008 ()

  • Width: 25 Millimeter
  • Outer Diameter: 8 Millimeter
  • Length: 11 Millimeter
12.300.1008

  • Ceramic spinal interbody fusion cage
Valeo II PL 11x25 0°, 7mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555123001007 ()

  • Length: 11 Millimeter
  • Outer Diameter: 7 Millimeter
  • Width: 25 Millimeter
12.300.1007

  • Ceramic spinal interbody fusion cage
Preference II Pedicle Screw System, Set Screw Caddy Implant Case Assy.
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555116000013 ()
11-6000-013

  • Device sterilization/disinfection container, reusable
Cross Connector Driver - Hex
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555115000067 ()
11-5000-067

  • Internal spinal fixation procedure kit, reusable
Head Body Manipulator, 6.0mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555114000030 ()
11-4000-030

  • Internal spinal fixation procedure kit, reusable
Driver, Thick Shaft, Final Tightening
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555114000014 ()
11-4000-014

  • Internal spinal fixation procedure kit, reusable
Valeo II LL - 22x45, 6°, 16mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110205916 ()

  • Length: 22 Millimeter
  • Width: 45 Millimeter
  • Height: 16 Millimeter
11.020.5916

  • Ceramic spinal interbody fusion cage
Valeo II LL - 22x45, 6°, 12mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110205912 ()

  • Length: 22 Millimeter
  • Width: 45 Millimeter
  • Height: 12 Millimeter
11.020.5912

  • Ceramic spinal interbody fusion cage
Valeo II LL - 22x45, 6°, 10mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110205910 ()

  • Height: 10 Millimeter
  • Width: 45 Millimeter
  • Length: 22 Millimeter
11.020.5910

  • Ceramic spinal interbody fusion cage
PLIF Inserter 10mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555317200001 ()
31-7200-001

  • Surgical implant/trial-implant/sizer holder, reusable
30-Dg_R_Serrated_#1
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315200008 ()
31-5200-008

  • Internal spinal fixation procedure kit, reusable
30-Dg_Lf_Serrated_#1
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315200006 ()
31-5200-006

  • Internal spinal fixation procedure kit, reusable
End_Cutting_Gouge
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315200001 ()
31-5200-001

  • Internal spinal fixation procedure kit, reusable
Cobb Elevator
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315100025 ()
31-5100-025

  • Internal spinal fixation procedure kit, reusable
Cobb Elevator
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315100019 ()
31-5100-019

  • Internal spinal fixation procedure kit, reusable
Complex Spine System Hook, Laminar Small, Narrow Blade 5.5
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555289000160 ()
28-9000-160

  • Bone-screw internal spinal fixation system hook
Complex Spine System Hook, Laminar Small, Wide Blade 5.5
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555289000150 ()
28-9000-150

  • Bone-screw internal spinal fixation system hook
ø7.2 Triple Lead Closed Polyaxial Screw Assembly, 110mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555287252110 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 110 Millimeter
28-7252-110

  • Spinal bone screw, non-bioabsorbable
ø7.2 Triple Lead Closed Polyaxial Screw Assembly, 100mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555287252100 ()

  • Length: 100 Millimeter
  • Outer Diameter: 7.2 Millimeter
28-7252-100

  • Spinal bone screw, non-bioabsorbable
ø7.2 Triple Lead Closed Polyaxial Screw Assembly, 90mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555287252090 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 90 Millimeter
28-7252-090

  • Spinal bone screw, non-bioabsorbable
ø7.2 Triple Lead Closed Polyaxial Screw Assembly, 80mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555287252080 ()

  • Length: 80 Millimeter
  • Outer Diameter: 7.2 Millimeter
28-7252-080

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 60mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5552-060

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 55mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552055 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
28-5552-055

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 50mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5552-050

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 45mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552045 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
28-5552-045

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 40mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5552-040

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 35mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552035 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
28-5552-035

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 30mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5552-030

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 25mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552025 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter
28-5552-025

  • Spinal bone screw, non-bioabsorbable
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