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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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ASTRA-OCT Spine System - M824A3XR39491

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 39-49mm
SPINECRAFT, LLC
A3X-R3949
Not in Commercial Distribution

  • 00193082082993 ()
  • M824A3XR39491 ()
A3X-R3949

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3XR35401

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 35-40mm
SPINECRAFT, LLC
A3X-R3540
Not in Commercial Distribution

  • 00193082082986 ()
  • M824A3XR35401 ()
A3X-R3540

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3XR31351

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 31-35mm
SPINECRAFT, LLC
A3X-R3135
Not in Commercial Distribution

  • 00193082082979 ()
  • M824A3XR31351 ()
A3X-R3135

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3TC55281

ASTRA-OCT Tandem Connector, 28mm, fitting Dia. 5.5/6.0mm (4 screw)
SPINECRAFT, LLC
A3T-C55-28
Not in Commercial Distribution

  • 00193082083167 ()
  • M824A3TC55281 ()
A3T-C55-28

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3TC55151

ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 5.5/6.0mm (2 screw)
SPINECRAFT, LLC
A3T-C55-15
Not in Commercial Distribution

  • 00193082083136 ()
  • M824A3TC55151 ()
A3T-C55-15

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3TC45281

ASTRA-OCT Tandem Connector, 28mm, fitting Dia. 4.5/Dia. 5.0mm (4 screw)
SPINECRAFT, LLC
A3T-C45-28
Not in Commercial Distribution

  • 00193082083150 ()
  • M824A3TC45281 ()
A3T-C45-28

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3TC45151

ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 4.5/Dia. 5.0mm (2 screw)
SPINECRAFT, LLC
A3T-C45-15
Not in Commercial Distribution

  • 00193082083129 ()
  • M824A3TC45151 ()
A3T-C45-15

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3TC35281

ASTRA-OCT Tandem Connector, 28mm, fitting Dia. 3.5/Dia. 4.0mm (4 screw)
SPINECRAFT, LLC
A3T-C35-28
Not in Commercial Distribution

  • 00193082083143 ()
  • M824A3TC35281 ()
A3T-C35-28

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3TC35151

ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 3.5/Dia. 4.0mm (2 screw)
SPINECRAFT, LLC
A3T-C35-15
Not in Commercial Distribution

  • 00193082083112 ()
  • M824A3TC35151 ()
A3T-C35-15

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3RT45500K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T45-500K
Not in Commercial Distribution

  • 00193082082726 ()
  • M824A3RT45500K1 ()
A3R-T45-500K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT455001

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T45-500
Not in Commercial Distribution

  • 00193082082146 ()
  • M824A3RT455001 ()
A3R-T45-500

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT45325K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325K
Not in Commercial Distribution

  • 00193082082719 ()
  • M824A3RT45325K1 ()
A3R-T45-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT453251

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325
Not in Commercial Distribution

  • 00193082082139 ()
  • M824A3RT453251 ()
A3R-T45-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT44500K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500K
Not in Commercial Distribution

  • 00193082082702 ()
  • M824A3RT44500K1 ()
A3R-T44-500K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT445001

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500
Not in Commercial Distribution

  • 00193082082122 ()
  • M824A3RT445001 ()
A3R-T44-500

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT44325K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325K
Not in Commercial Distribution

  • 00193082082696 ()
  • M824A3RT44325K1 ()
A3R-T44-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT443251

ASTRA-OCT Dia. 4mm Ti Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325
Not in Commercial Distribution

  • 00193082082115 ()
  • M824A3RT443251 ()
A3R-T44-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT35500K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500K
Not in Commercial Distribution

  • 00193082082436 ()
  • M824A3RT35500K1 ()
A3R-T35-500K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT355001

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500
Not in Commercial Distribution

  • 00193082081859 ()
  • M824A3RT355001 ()
A3R-T35-500

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT35325K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325K
Not in Commercial Distribution

  • 00193082082429 ()
  • M824A3RT35325K1 ()
A3R-T35-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT353251

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325
Not in Commercial Distribution

  • 00193082081842 ()
  • M824A3RT353251 ()
A3R-T35-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT34500K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T34-500K
Not in Commercial Distribution

  • 00193082082412 ()
  • M824A3RT34500K1 ()
A3R-T34-500K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT345001

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T34-500
Not in Commercial Distribution

  • 00193082081835 ()
  • M824A3RT345001 ()
A3R-T34-500

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT34325K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T34-325K
Not in Commercial Distribution

  • 00193082082405 ()
  • M824A3RT34325K1 ()
A3R-T34-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT343251

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T34-325
Not in Commercial Distribution

  • 00193082081828 ()
  • M824A3RT343251 ()
A3R-T34-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40450K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 450mm
SPINECRAFT, LLC
A3R-40-450K
Not in Commercial Distribution

  • 00193082082689 ()
  • M824A3R40450K1 ()
A3R-40-450K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R404501

ASTRA-OCT Dia. 4mm Ti Straight Rod, 450mm
SPINECRAFT, LLC
A3R-40-450
Not in Commercial Distribution

  • 00193082082108 ()
  • M824A3R404501 ()
A3R-40-450

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40325K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 325mm
SPINECRAFT, LLC
A3R-40-325K
Not in Commercial Distribution

  • 00193082082672 ()
  • M824A3R40325K1 ()
A3R-40-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R403251

ASTRA-OCT Dia. 4mm Ti Straight Rod, 325mm
SPINECRAFT, LLC
A3R-40-325
Not in Commercial Distribution

  • 00193082082092 ()
  • M824A3R403251 ()
A3R-40-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40300K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 300mm
SPINECRAFT, LLC
A3R-40-300K
Not in Commercial Distribution

  • 00193082082665 ()
  • M824A3R40300K1 ()
A3R-40-300K

  • Bone-screw internal spinal fixation system rod
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