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 Rod, ø5.5mm x 80mm, Straight
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110071080 ()

  • Length: 80 Millimeter
  • Outer Diameter: 5.5 Millimeter
11.007.1080

  • Bone-screw internal spinal fixation system rod
Valeo PL,9x25, 0°, 12mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555110043012 ()

  • Height: 12 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3012

  • Vertebral body prosthesis
Valeo PL,9x25, 0°, 10mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043010 ()

  • Height: 10 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3010

  • Ceramic spinal interbody fusion cage
Valeo PL,9x25, 0°, 8mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043008 ()

  • Height: 8 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3008

  • Ceramic spinal interbody fusion cage
Straight Rod 6.0mm, 600mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200600 ()

  • Length: 600 Millimeter
  • Outer Diameter: 6 Millimeter
10-2200-600

  • Bone-screw internal spinal fixation system rod
Straight Rod 6.0mm, 350mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200350 ()

  • Length: 350 Millimeter
  • Outer Diameter: 6 Millimeter
10-2200-350

  • Bone-screw internal spinal fixation system rod
Caddie pedicle Locking Cap Standard and Large, Complex Spine
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555281000058 ()
28-1000-058

  • Device sterilization/disinfection container, reusable
Caddie, Lateral Offset, Rod Connectors Complex Spine
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555281000055 ()
28-1000-055

  • Device sterilization/disinfection container, reusable
Rod Gripper
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555274000091 ()
27-4000-091

  • Internal spinal fixation procedure kit, reusable
Polyaxial Screw Driver
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555273000001 ()
27-3000-001

  • Internal spinal fixation procedure kit, reusable
Polyaxial Reduction Screwdriver Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555272000003 ()
27-2000-003

  • Internal spinal fixation procedure kit, reusable
Triple Lead Screw Tap Assembly 7.2mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555271000072 ()
27-1000-072

  • Spinal bone screw, non-bioabsorbable
Triple Lead Screw Tap Assembly 4.5mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555271000045 ()
27-1000-045

  • Spinal bone screw, non-bioabsorbable
Preference 2 Mini Rod Caddy Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555244000166 ()
24-4000-166

  • Instrument tray, reusable
Preference 2 Mini 7.2mm Screw Caddy Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555244000160 ()
24-4000-160

  • Instrument tray, reusable
Preference 2 Mini 6.5mm Screw Caddy Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555244000157 ()
24-4000-157

  • Instrument tray, reusable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207203030 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 30 Millimeter
20-7203-030

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 60mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504060 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 60 Millimeter
20-6504-060

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504055 ()

  • Length: 55 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-055

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-045

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504040 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter
20-6504-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504025 ()

  • Length: 25 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-025

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 60mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206503060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6503-060

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206503055 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 55 Millimeter
20-6503-055

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206503050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6503-050

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206503040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6503-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206503025 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 25 Millimeter
20-6503-025

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504055 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
20-5504-055

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5504-050

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504045 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
20-5504-045

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5504-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504035 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
20-5504-035

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5504-030

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504025 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter
20-5504-025

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205503055 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5503-055

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205503050 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter
20-5503-050

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205503045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5503-045

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205503040 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 40 Millimeter
20-5503-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205503035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5503-035

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205503030 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter
20-5503-030

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205503025 ()

  • Length: 25 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5503-025

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4504-045

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504040 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 40 Millimeter
20-4504-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4504-035

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504030 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 30 Millimeter
20-4504-030

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504025 ()

  • Length: 25 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4504-025

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204503045 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45 Millimeter
20-4503-045

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204503040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4503-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204503035 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter
20-4503-035

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204503030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4503-030

  • Spinal bone screw, non-bioabsorbable
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