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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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Valeo Spacer System - M555910013005

Right Cutting Cup Long Curette
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910013005 ()
91.001.3005

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910013004

Left Cutting Cup Long Curette
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910013004 ()
91.001.3004

  • Internal spinal fixation procedure kit, reusable

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

Valeo Spacer System - M555910013016

Serrated Cup Curette, 4
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910013016 ()
91.001.3016

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910013010

Valeo Straight Rasp
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910013010 ()
91.001.3010

  • Internal spinal fixation procedure kit, reusable

Phantom Plus Cage System - M555312500002

Shaft, Short Handle
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555312500002 ()
31-2500-002

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910157070

Trial Inserter Handle
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555910157070 ()
91.015.7070

  • Internal spinal fixation procedure kit, single-use
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