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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 Fusion System - M555110091022

Valeo Corpectomy 16x12mm, 0°, 22mm Height
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110091022 ()

  • Length: 16 Millimeter
  • Width: 12 Millimeter
  • Height: 22 Millimeter
11.009.1022

  • Ceramic spinal interbody fusion cage

Valeo Fusion System - M555110091021

Valeo Corpectomy 16x12mm, 0°, 21mm Height
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555110091021 ()

  • Height: 21 Millimeter
  • Width: 12 Millimeter
  • Length: 16 Millimeter
11.009.1021

  • Ceramic spinal interbody fusion cage

Valeo Fusion System - M555110091020

Valeo Corpectomy 16x12mm, 0°, 20mm Height
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555110091020 ()

  • Length: 16 Millimeter
  • Width: 12 Millimeter
  • Height: 20 Millimeter
11.009.1020

  • Bone-screw internal spinal fixation system, sterile

Phantom Plus Cage System - M555317200001

PLIF Inserter 10mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555317200001 ()
31-7200-001

  • Surgical implant/trial-implant/sizer holder, reusable

Phantom Plus Cage System - M555315500004

Slap Hammer
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315500004 ()
31-5500-004

  • Internal spinal fixation procedure kit, reusable

Phantom Plus Cage System - M555315200008

30-Dg_R_Serrated_#1
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315200008 ()
31-5200-008

  • Internal spinal fixation procedure kit, reusable

Preference 2 - M555289000160

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

Preference 2 - M555289000150

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

Preference 2 - M555286552060

ø6.5 Triple Lead Closed Polyaxial Screw Assembly, 60mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555286552060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 6.5 Millimeter
28-6552-060

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286552055

ø6.5 Triple Lead Closed Polyaxial Screw Assembly, 55mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555286552055 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 55 Millimeter
28-6552-055

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286552050

ø6.5 Triple Lead Closed Polyaxial Screw Assembly, 50mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555286552050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 6.5 Millimeter
28-6552-050

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286552045

ø6.5 Triple Lead Closed Polyaxial Screw Assembly, 45mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555286552045 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 45 Millimeter
28-6552-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286552040

ø6.5 Triple Lead Closed Polyaxial Screw Assembly, 40mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555286552040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 6.5 Millimeter
28-6552-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286552035

ø6.5 Triple Lead Closed Polyaxial Screw Assembly, 35mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555286552035 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter
28-6552-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286552025

ø6.5 Triple Lead Closed Polyaxial Screw Assembly, 25mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555286552025 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 25 Millimeter
28-6552-025

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284000400

Long Rod Template, 5.5mm x 400mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555284000400 ()
28-4000-400

  • Spinal implant trial

Preference 2 - M555281000053

7.2mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000053 ()
28-1000-053

  • Device sterilization/disinfection container, reusable

Preference 2 - M555281000052

6.5mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000052 ()
28-1000-052

  • Device sterilization/disinfection container, reusable

Preference 2 - M555281000051

5.5mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000051 ()
28-1000-051

  • Device sterilization/disinfection container, reusable

Preference 2 - M555281000050

4.5mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000050 ()
28-1000-050

  • Device sterilization/disinfection container, reusable
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