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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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Radixact Treatment Delivery System
Accuray Incorporated
1060000
In Commercial Distribution

N/A

  • Linear accelerator system
SPIRA®-A Integrated,Trial, 24x32mm, 8° Lordotic, 17mm
CAMBER SPINE TECHNOLOGIES, LLC
SAZ-102-005
In Commercial Distribution

  • B030SAZ1020050 ()
N/A

  • Spinal implant trial
SPIRA®-A Integrated,Trial, 24x32mm, 8° Lordotic, 15mm
CAMBER SPINE TECHNOLOGIES, LLC
SAZ-102-004
In Commercial Distribution

  • B030SAZ1020040 ()
N/A

  • Spinal implant trial
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 95mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8595
In Commercial Distribution

  • B030ORM185950 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 90mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8590
In Commercial Distribution

  • B030ORM185900 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 85mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8585
In Commercial Distribution

  • B030ORM185850 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 80mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8580
In Commercial Distribution

  • B030ORM185800 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 75mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8575
In Commercial Distribution

  • B030ORM185750 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 70mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8570
In Commercial Distribution

  • B030ORM185700 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 65mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8565
In Commercial Distribution

  • B030ORM185650 ()
N/A

  • Spinal bone screw, non-bioabsorbable
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