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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Tray 1, Phantom Plus PLIF, TLIF System Case 2
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000203 ()
31-6000-203

  • Instrument tray, reusable
Lid, Phantom Plus PLIF, TLIF System Case 1
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000104 ()
31-6000-104

  • Instrument tray, reusable
Lid, Phantom Plus PLIF, TLIF System Case 2
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000103 ()
31-6000-103

  • Instrument tray, reusable
Shaft, Long Handle
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555315500006 ()
31-5500-006

  • Internal spinal fixation procedure kit, reusable
Long Handle Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555315500003 ()
31-5500-003

  • Internal spinal fixation procedure kit, reusable
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 Cross Connectors, Complex Spine
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555281000057 ()
28-1000-057

  • Device sterilization/disinfection container, reusable
Caddie, Axial and Side to Side Rod Connectors, Complex Spine
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555281000056 ()
28-1000-056

  • 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
Caddie, Hooks, Complex Spine
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555281000054 ()
28-1000-054

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

  • M555274000091 ()
27-4000-091

  • Internal spinal fixation procedure kit, reusable
Head Positioner - Rod Pusher
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555274000006 ()
27-4000-006

  • Internal spinal fixation procedure kit, reusable
Rod Inserting Forceps
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555274000004 ()
27-4000-004

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

  • M555272000001 ()
27-2000-001

  • Internal spinal fixation procedure kit, reusable
Triple Lead Screw Tap Assembly 6.5mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555271000065 ()
27-1000-065

  • Spinal bone screw, non-bioabsorbable
Pedicle Finder
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555246000007 ()
24-6000-007

  • Internal spinal fixation procedure kit, reusable
Lamnar Finder
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555246000006 ()
24-6000-006

  • Internal spinal fixation procedure kit, reusable
Counter Torque, Complex Spine
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555244000185 ()
24-4000-185

  • Internal spinal fixation procedure kit, reusable
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
Preference 2 Mini Tray 2 Optional Inst. Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555244000154 ()
24-4000-154

  • Instrument tray, reusable
Preference 2 Mini Set Tray 1 Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555244000150 ()
24-4000-150

  • Instrument tray, reusable
Persuader
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555244000102 ()
24-4000-102

  • Internal spinal fixation procedure kit, reusable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 60mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-060

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-050

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204045 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 45 Millimeter
20-7204-045

  • 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 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504050 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter
20-6504-050

  • 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 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-035

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504030 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 30 Millimeter
20-6504-030

  • 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, 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 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, 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
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