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 LL - 22x40, 6°, 12mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110205812 ()

  • Height: 12 Millimeter
  • Width: 40 Millimeter
  • Length: 22 Millimeter
11.020.5812

  • Ceramic spinal interbody fusion cage
Tamp, DRC
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316900105 ()
31-6900-105

  • Orthopaedic implant impactor, reusable
Positioner, DRC
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316900101 ()
31-6900-101

  • Orthopaedic implant impactor, reusable
Tray 2, Phantom Plus PLIF, TLIF System Case 1
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555316000304 ()
31-6000-304

  • Instrument tray, reusable
45° Double Sided Rasp
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555315200005 ()
31-5200-005

  • Internal spinal fixation procedure kit, reusable
30° Left Fenestrated Cup Curette
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555315200002 ()
31-5200-002

  • Internal spinal fixation procedure kit, reusable
Nerve_Root_Retractor_Sm_90_Dg
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555315000003 ()
31-5000-003

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

  • M555315000002 ()
31-5000-002

  • Internal spinal fixation procedure kit, reusable
Nerve_Root_Retractor_Lg_90_Dg
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555315000001 ()
31-5000-001

  • Internal spinal fixation procedure kit, reusable
Complex Spine System Hook, Transverse Process, Right 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555289000320 ()
28-9000-320

  • Bone-screw internal spinal fixation system hook
Complex Spine System Hook, Transverse Process, Left 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555289000310 ()
28-9000-310

  • Bone-screw internal spinal fixation system hook
Complex Spine System Hook, Pedicle, Small 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555289000210 ()
28-9000-210

  • Bone-screw internal spinal fixation system hook
Complex Spine System Hook, Pedicle, Large 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555289000200 ()
28-9000-200

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

  • M555289000140 ()
28-9000-140

  • Bone-screw internal spinal fixation system hook
Complex Spine System Hook, Laminar, Offset Left 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555289000120 ()
28-9000-120

  • Bone-screw internal spinal fixation system hook
Complex Spine System Hook, Laminar, Angled Down 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555289000110 ()
28-9000-110

  • Bone-screw internal spinal fixation system hook
Complex Spine System Hook, Laminar, Angled Up 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555289000100 ()
28-9000-100

  • Bone-screw internal spinal fixation system hook
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 8.2mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555271000082 ()
27-1000-082

  • Spinal bone screw, non-bioabsorbable
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 5.5mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555271000055 ()

  • Outer Diameter: 5.5 Millimeter
27-1000-055

  • 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
Clamshell Connector Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555252300007 ()
25-2300-007

  • Bone-screw internal spinal fixation system connector
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204055 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 55 Millimeter
20-7204-055

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204035 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 35 Millimeter
20-7204-035

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-030

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 60mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207203060 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 60 Millimeter
20-7203-060

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207203055 ()

  • Length: 55 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7203-055

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

  • M555207203050 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 50 Millimeter
20-7203-050

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

  • M555207203045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7203-045

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207203040 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 40 Millimeter
20-7203-040

  • Spinal bone screw, non-bioabsorbable
6.0 Slot, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207203035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7203-035

  • Spinal bone screw, non-bioabsorbable
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
Ring Handled Spacer Assembly
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910074112 ()
91.007.4112

  • Bone-screw internal spinal fixation system, sterile
Ø5.0mm Flexible Rod Templates Length (80/150)
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073150 ()
91.007.3150

  • Bone-screw internal spinal fixation system, sterile
Valeo PS Distractor
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073110 ()
91.007.3110

  • Bone-screw internal spinal fixation system, sterile
Ø5.0mm Flexible Rod Templates Length (80/150)
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073080 ()
91.007.3080

  • Bone-screw internal spinal fixation system, sterile
Rod Cutter, Ratchet 5.5mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073039 ()
91.007.3039

  • Bone-screw internal spinal fixation system, sterile
Valeo - PSS, Rod Cutter
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073019 ()
91.007.3019

  • Bone-screw internal spinal fixation system, sterile
French Rod Bender
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073016 ()
91.007.3016

  • Bone-screw internal spinal fixation system, sterile
Valeo-PS, Counter-Torque
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073015 ()
91.007.3015

  • Bone-screw internal spinal fixation system, sterile
Valeo PS Driver, Final Tightening
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073013 ()
91.007.3013

  • Bone-screw internal spinal fixation system, sterile
Valeo PS Driver, Set Screw Starter
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073011 ()
91.007.3011

  • Bone-screw internal spinal fixation system, sterile
Valeo - PSS, Distractor
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073010 ()
91.007.3010

  • Bone-screw internal spinal fixation system, sterile
Valeo - PSS, Compressor
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073009 ()
91.007.3009

  • Bone-screw internal spinal fixation system, sterile
Rod Pusher, 5.5mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073007 ()
91.007.3007

  • Bone-screw internal spinal fixation system, sterile
Power Rod Holder
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073006 ()
91.007.3006

  • Bone-screw internal spinal fixation system, sterile
Ø5.5mm Rod Holder
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910073005 ()
91.007.3005

  • Bone-screw internal spinal fixation system, sterile
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