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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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AART Calf Implant Sizer - B4905023012E0

Szr - Calf Sty 3 Sz 1 NS
Aart
E
In Commercial Distribution

  • B4905023012E0 ()
502-301-2E

  • Silicone-block tissue reconstructive material

AART Calf Implant - B490502300E0

Calf Sty 3 Sz 0 Sterile
Aart
E
In Commercial Distribution

  • B490502300E0 ()
502-300E

  • Silicone-block tissue reconstructive material

AART Calf Implant Sizer - B4905023002E0

Szr - Calf Sty 3 Sz 0 NS
Aart
E
In Commercial Distribution

  • B4905023002E0 ()
502-300-2E

  • Silicone-block tissue reconstructive material

LUXISSE - 00817724028919

YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
E
Not in Commercial Distribution

  • 00817724028919 ()

  • Outer Diameter: 94 Millimeter
  • Height: 30 Millimeter
MDDK3702ZF30OM3

  • Dental appliance fabrication material, ceramic

Valeo Spacer System - M555910157070

Trial Inserter Handle
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555910157070 ()
91.015.7070

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910021116

Casper Pin Distraction Screw, 16mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910021116 ()
91.002.1116

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910021114

Casper Pin Distraction Screw, 14mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910021114 ()
91.002.1114

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910021112

Casper Pin Distraction Screw, 12mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910021112 ()
91.002.1112

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910014115

Lumbar Mallet
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910014115 ()
91.001.4115

  • Internal spinal fixation procedure kit, reusable

Preference 2 - M555287250110

ø7.2 Triple Lead Screw Assembly, 110mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555287250110 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 110 Millimeter
28-7250-110

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555287250100

ø7.2 Triple Lead Screw Assembly, 100mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555287250100 ()

  • Length: 100 Millimeter
  • Outer Diameter: 7.2 Millimeter
28-7250-100

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555287250090

ø7.2 Triple Lead Screw Assembly, 90mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555287250090 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 90 Millimeter
28-7250-090

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555287250040

ø7.2 Triple Lead Screw Assembly, 40mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555287250040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 7.2 Millimeter
28-7250-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555287250035

ø7.2 Triple Lead Screw Assembly, 35mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555287250035 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 35 Millimeter
28-7250-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555287250030

ø7.2 Triple Lead Screw Assembly, 30mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555287250030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 7.2 Millimeter
28-7250-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555287250025

ø7.2 Triple Lead Screw Assembly, 25mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555287250025 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 25 Millimeter
28-7250-025

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286550060

ø6.5 Triple Lead Screw Assembly, 60mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555286550060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 6.5 Millimeter
28-6550-060

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286550055

ø6.5 Triple Lead Screw Assembly, 55mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555286550055 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 55 Millimeter
28-6550-055

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286550040

ø6.5 Triple Lead Screw Assembly, 40mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555286550040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 6.5 Millimeter
28-6550-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286550030

ø6.5 Triple Lead Screw Assembly, 30mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555286550030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 6.5 Millimeter
28-6550-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555286550025

ø6.5 Triple Lead Screw Assembly, 25mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555286550025 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 25 Millimeter
28-6550-025

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555285550060

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

Preference 2 - M555285550025

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

Preference 2 - M555284550050

ø4.5 Triple Lead Screw Assembly, 50mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-050

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284550045

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

Preference 2 - M555284550040

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

Preference 2 - M555284550035

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

Preference 2 - M555284550030

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

Preference 2 - M555284550025

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

Valeo Spacer System - M555916006211

Valeo II C, 16x14 0° 11-12mm -0.5 Stop
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555916006211 ()

  • Height: 11 Millimeter
  • Length: 16 Millimeter
  • Width: 14 Millimeter
91.600.6211

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916006209

Valeo II C, 16x14 0° 9-10mm -0.5 Stop
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555916006209 ()

  • Height: 9 Millimeter
  • Width: 14 Millimeter
  • Length: 16 Millimeter
91.600.6209

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916006207

Valeo II C, 16x14 0° 7-8mm -0.5 Stop
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555916006207 ()

  • Height: 7 Millimeter
  • Length: 16 Millimeter
  • Width: 14 Millimeter
91.600.6207

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555916006205

Valeo II C, 16x14 0° 5-6mm -0.5 Stop
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555916006205 ()

  • Height: 5 Millimeter
  • Width: 14 Millimeter
  • Length: 16 Millimeter
91.600.6205

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911136022

PL/OL Inserter Tip Natural Peek
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911136022 ()
91.113.6022

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133212

Valeo II 9x21 6° PL Trials, 12mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133212 ()
91.113.3212

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133211

Valeo II 9x21 6° PL Trials, 11mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133211 ()
91.113.3211

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133210

Valeo II 9x21 6° PL Trials, 10mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133210 ()
91.113.3210

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133209

Valeo II 9x21 6° PL Trials, 9mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133209 ()
91.113.3209

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133208

Valeo II 9x21 6° PL Trials, 8mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133208 ()
91.113.3208

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133207

Valeo II 9x21 6° PL Trials, 7mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133207 ()
91.113.3207

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133116

Valeo II 9x21 0° PL Trials, 16mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133116 ()
91.113.3116

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133115

Valeo II 9x21 0° PL Trials, 15mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133115 ()
91.113.3115

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133114

Valeo II 9x21 0° PL Trials, 14mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133114 ()
91.113.3114

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133113

Valeo II 9x21 0° PL Trials, 13mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133113 ()
91.113.3113

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133112

Valeo II 9x21 0° PL Trials, 12mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133112 ()
91.113.3112

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133111

Valeo II 9x21 0° PL Trials, 11mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133111 ()
91.113.3111

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133110

Valeo II 9x21 0° PL Trials, 10mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133110 ()
91.113.3110

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133109

Valeo II 9x21 0° PL Trials, 9mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133109 ()
91.113.3109

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133108

Valeo II 9x21 0° PL Trials, 8mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133108 ()
91.113.3108

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555911133107

Valeo II 9x21 0° PL Trials, 7mm
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911133107 ()
91.113.3107

  • Internal spinal fixation procedure kit, single-use
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