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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 - M824A3XS451

ASTRA-OCT Screw-to-Screw Cross Connector, 45mm
SPINECRAFT, LLC
A3X-S45
Not in Commercial Distribution

  • 00193082083037 ()
  • M824A3XS451 ()
A3X-S45

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3XS371

ASTRA-OCT Screw-to-Screw Cross Connector, 37mm
SPINECRAFT, LLC
A3X-S37
Not in Commercial Distribution

  • 00193082083013 ()
  • M824A3XS371 ()
A3X-S37

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3XS331

ASTRA-OCT Screw-to-Screw Cross Connector, 33mm
SPINECRAFT, LLC
A3X-S33
Not in Commercial Distribution

  • 00193082083006 ()
  • M824A3XS331 ()
A3X-S33

  • 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 - 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 - 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 - 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 - 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 - 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
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