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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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
Valeo II OL 9x32 0°, 7mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111136007 ()

  • Length: 9 Millimeter
  • Outer Diameter: 7 Millimeter
  • Width: 32 Millimeter
11.113.6007

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x29 0°, 16mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111135016 ()

  • Width: 29 Millimeter
  • Outer Diameter: 16 Millimeter
  • Length: 9 Millimeter
11.113.5016

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x29 0°, 15mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111135015 ()

  • Length: 9 Millimeter
  • Outer Diameter: 15 Millimeter
  • Width: 29 Millimeter
11.113.5015

  • Ceramic spinal interbody fusion cage
Valeo II OL 9x29 0°, 14mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111135014 ()

  • Width: 29 Millimeter
  • Outer Diameter: 14 Millimeter
  • Length: 9 Millimeter
11.113.5014

  • Ceramic spinal interbody fusion cage
Valeo II PL 9x21 0°, 15mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111131815 ()

  • Width: 21 Millimeter
  • Outer Diameter: 15 Millimeter
  • Length: 9 Millimeter
11.113.1815

  • Ceramic spinal interbody fusion cage
Valeo II PL 9x21 0°, 12mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111131812 ()

  • Length: 9 Millimeter
  • Outer Diameter: 12 Millimeter
  • Width: 21 Millimeter
11.113.1812

  • Ceramic spinal interbody fusion cage
Valeo II PL 9x21 0°, 10mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111131810 ()

  • Length: 9 Millimeter
  • Outer Diameter: 10 Millimeter
  • Width: 21 Millimeter
11.113.1810

  • Ceramic spinal interbody fusion cage
Valeo II PL 9x21 0°, 8mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555111131808 ()

  • Length: 9 Millimeter
  • Outer Diameter: 8 Millimeter
  • Width: 21 Millimeter
11.113.1808

  • Ceramic spinal interbody fusion cage
Valeo II AL, 30x24, 4°, 22mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555110166422 ()

  • Height: 22 Millimeter
  • Width: 24 Millimeter
  • Length: 30 Millimeter
11.016.6422

  • Ceramic spinal interbody fusion cage
Valeo II AL, 30x24, 4°, 20mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555110166420 ()

  • Height: 20 Millimeter
  • Width: 24 Millimeter
  • Length: 30 Millimeter
11.016.6420

  • Ceramic spinal interbody fusion cage
Valeo II AL, 30x24, 4°, 18mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555110166418 ()

  • Height: 18 Millimeter
  • Width: 24 Millimeter
  • Length: 30 Millimeter
11.016.6418

  • Ceramic spinal interbody fusion cage
Valeo II AL, 30x24, 4°, 17mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555110166417 ()

  • Length: 30 Millimeter
  • Width: 24 Millimeter
  • Height: 17 Millimeter
11.016.6417

  • Ceramic spinal interbody fusion cage
Valeo II AL, 30x24, 4°, 15mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555110166415 ()

  • Length: 30 Millimeter
  • Width: 24 Millimeter
  • Height: 15 Millimeter
11.016.6415

  • Ceramic spinal interbody fusion cage
ø5.5 Triple Lead Screw Assembly, 60mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5550-060

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Screw Assembly, 55mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550055 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
28-5550-055

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Screw Assembly, 50mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5550-050

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Screw Assembly, 45mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550045 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
28-5550-045

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Screw Assembly, 40mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5550-040

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Screw Assembly, 35mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550035 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
28-5550-035

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Screw Assembly, 30mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5550-030

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Screw Assembly, 25mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555285550025 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter
28-5550-025

  • Spinal bone screw, non-bioabsorbable
ø4.5 Triple Lead Screw Assembly, 60mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-060

  • Spinal bone screw, non-bioabsorbable
ø4.5 Triple Lead Screw Assembly, 55mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550055 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 55 Millimeter
28-4550-055

  • Spinal bone screw, non-bioabsorbable
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
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