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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ø4.5 Triple Lead Screw Assembly, 45mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550045 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45 Millimeter
28-4550-045

  • Spinal bone screw, non-bioabsorbable
ø4.5 Triple Lead Screw Assembly, 40mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-040

  • Spinal bone screw, non-bioabsorbable
ø4.5 Triple Lead Screw Assembly, 35mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550035 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter
28-4550-035

  • Spinal bone screw, non-bioabsorbable
ø4.5 Triple Lead Screw Assembly, 30mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-030

  • Spinal bone screw, non-bioabsorbable
ø4.5 Triple Lead Screw Assembly, 25mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550025 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 25 Millimeter
28-4550-025

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 110mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200110 ()

  • Length: 110 Millimeter
  • Outer Diameter: 8.2 Millimeter
25-8200-110

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 100mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200100 ()

  • Outer Diameter: 8.2 Millimeter
  • Length: 100 Millimeter
25-8200-100

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 90mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200090 ()

  • Length: 90 Millimeter
  • Outer Diameter: 8.2 Millimeter
25-8200-090

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 80mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200080 ()

  • Outer Diameter: 8.2 Millimeter
  • Length: 80 Millimeter
25-8200-080

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 70mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200070 ()

  • Length: 70 Millimeter
  • Outer Diameter: 8.2 Millimeter
25-8200-070

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 60mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200060 ()

  • Outer Diameter: 8.2 Millimeter
  • Length: 60 Millimeter
25-8200-060

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 55mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200055 ()

  • Length: 55 Millimeter
  • Outer Diameter: 8.2 Millimeter
25-8200-055

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 50mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200050 ()

  • Outer Diameter: 8.2 Millimeter
  • Length: 50 Millimeter
25-8200-050

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 45mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 8.2 Millimeter
25-8200-045

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 40mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200040 ()

  • Outer Diameter: 8.2 Millimeter
  • Length: 40 Millimeter
25-8200-040

  • Spinal bone screw, non-bioabsorbable
ø8.2mm Polyaxial Screw for ø5.5mm Rod, 35mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258200035 ()

  • Outer Diameter: 8.2 Millimeter
  • Length: 35 Millimeter
25-8200-035

  • Spinal bone screw, non-bioabsorbable
5.5mm Lateral Offset HF, 80mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258000080 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 80 Millimeter
25-8000-080

  • Bone-screw internal spinal fixation system connector
5.5mm Lateral Offset HF, 45mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258000045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter
25-8000-045

  • Bone-screw internal spinal fixation system connector
5.5mm Lateral Offset HF, 30mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258000030 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter
25-8000-030

  • Bone-screw internal spinal fixation system connector
5.5mm Lateral Offset HF, 18mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555258000018 ()

  • Length: 18 Millimeter
  • Outer Diameter: 5.5 Millimeter
25-8000-018

  • Bone-screw internal spinal fixation system connector
Axial Rod Connector Assembly, 5.5mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555252500001 ()

  • Outer Diameter: 5.5 Millimeter
25-2500-001

  • Bone-screw internal spinal fixation system connector
Rod Connector, Short, 5.5mm Rod Assembly
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555252400001 ()

  • Outer Diameter: 5.5 Millimeter
25-2400-001

  • Bone-screw internal spinal fixation system connector
Stabilizing Sleeve
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555211000020 ()
21-1000-020

  • Internal spinal fixation procedure kit, reusable
8.2mm Caddy Block
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555159000329 ()
15-9000-329

  • Device sterilization/disinfection container, reusable
Valeo II C 16x14 , 14mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002014 ()

  • Height: 14 Millimeter
12.600.2014

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 13mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002013 ()

  • Height: 13 Millimeter
12.600.2013

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 12mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002012 ()

  • Height: 12 Millimeter
12.600.2012

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 11mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002011 ()

  • Height: 11 Millimeter
12.600.2011

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 10mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002010 ()

  • Height: 10 Millimeter
12.600.2010

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 9mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002009 ()

  • Height: 9 Millimeter
12.600.2009

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 8mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002008 ()

  • Height: 8 Millimeter
12.600.2008

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 7mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002007 ()

  • Height: 7 Millimeter
12.600.2007

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 6mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002006 ()

  • Height: 6 Millimeter
12.600.2006

  • Ceramic spinal interbody fusion cage
Valeo II C 16x14 , 5mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555126002005 ()

  • Height: 5 Millimeter
12.600.2005

  • Ceramic spinal interbody fusion cage
Preference II Pedicle Screw System, Implant Case
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555116000001 ()
11-6000-001

  • Device sterilization/disinfection container, reusable
Distractor, Single Lever
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555115000002 ()
11-5000-002

  • Orthopaedic surgical distractor, internal
Compressor, Single Level
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555115000001 ()
11-5000-001

  • Internal spinal fixation procedure kit, reusable
Blocker Tightener, Provisional
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000034 ()
11-4000-034

  • Internal spinal fixation procedure kit, reusable
Power Rod Holder, 6mm Diameter
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000005 ()
11-4000-005

  • Surgical implant/trial-implant/sizer holder, reusable
Rod Holder
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000004 ()
11-4000-004

  • Surgical implant/trial-implant/sizer holder, reusable
Rod Bender, French
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000001 ()
11-4000-001

  • Manual orthopaedic bender, reusable
Valeo II OL 9x32 0°, 16mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136016 ()

  • Width: 32 Millimeter
  • Outer Diameter: 16 Millimeter
  • Length: 9 Millimeter
11.113.6016

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 15mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136015 ()

  • Length: 9 Millimeter
  • Outer Diameter: 15 Millimeter
  • Width: 32 Millimeter
11.113.6015

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 14mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136014 ()

  • Width: 32 Millimeter
  • Outer Diameter: 14 Millimeter
  • Length: 9 Millimeter
11.113.6014

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 13mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136013 ()

  • Length: 9 Millimeter
  • Outer Diameter: 13 Millimeter
  • Width: 32 Millimeter
11.113.6013

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 12mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136012 ()

  • Width: 32 Millimeter
  • Outer Diameter: 12 Millimeter
  • Length: 9 Millimeter
11.113.6012

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 11mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136011 ()

  • Length: 9 Millimeter
  • Outer Diameter: 11 Millimeter
  • Width: 32 Millimeter
11.113.6011

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 10mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136010 ()

  • Width: 32 Millimeter
  • Outer Diameter: 10 Millimeter
  • Length: 9 Millimeter
11.113.6010

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 9mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136009 ()

  • Length: 9 Millimeter
  • Outer Diameter: 9 Millimeter
  • Width: 32 Millimeter
11.113.6009

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x32 0°, 8mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136008 ()

  • Width: 32 Millimeter
  • Outer Diameter: 8 Millimeter
  • Length: 9 Millimeter
11.113.6008

  • Ceramic spinal interbody fusion cage
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