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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 - M824A3OS45081

ASTRA-OCT Dia. 4.5mm Occipital Bone Screw, 8mm
SPINECRAFT, LLC
A3OS-4508
Not in Commercial Distribution

  • 00193082083655 ()
  • M824A3OS45081 ()
A3OS-4508

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OS45061

ASTRA-OCT Dia. 4.5mm Occipital Bone Screw, 6mm
SPINECRAFT, LLC
A3OS-4506
Not in Commercial Distribution

  • 00193082083648 ()
  • M824A3OS45061 ()
A3OS-4506

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OR409032K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 325mm x 90 deg (90 deg)
SPINECRAFT, LLC
A3OR-40-9032K
Not in Commercial Distribution

  • 00193082082818 ()
  • M824A3OR409032K1 ()
A3OR-40-9032K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR4090321

ASTRA-OCT Dia. 4mm Ti Occipital Rod, 325mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-40-9032
Not in Commercial Distribution

  • 00193082082238 ()
  • M824A3OR4090321 ()
A3OR-40-9032

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR406020K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 200mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-40-6020K
Not in Commercial Distribution

  • 00193082082733 ()
  • M824A3OR406020K1 ()
A3OR-40-6020K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR359032K1

ASTRA-OCT Dia. 3.5mm CoCr Occipital Rod, 325mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-35-9032K
Not in Commercial Distribution

  • 00193082082528 ()
  • M824A3OR359032K1 ()
A3OR-35-9032K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OPA421

ASTRA-OCT Adjustable Occipital Plate, 42mm
SPINECRAFT, LLC
A3OP-A42
Not in Commercial Distribution

  • 00193082083624 ()
  • M824A3OPA421 ()
A3OP-A42

  • Spinal fixation plate, non-bioabsorbable

ASTRA-OCT Spine System - M824A3OPA361

ASTRA-OCT Adjustable Occipital Plate, 36mm
SPINECRAFT, LLC
A3OP-A36
Not in Commercial Distribution

  • 00193082083617 ()
  • M824A3OPA361 ()
A3OP-A36

  • Spinal fixation plate, non-bioabsorbable

ASTRA-OCT Spine System - M824A3LOSA301

ASTRA-OCT Open Side-loading Angled Lateral Connector, 30mm
SPINECRAFT, LLC
A3L-OSA30
Not in Commercial Distribution

  • 00193082083341 ()
  • M824A3LOSA301 ()
A3L-OSA30

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3LOSA251

ASTRA-OCT Open Side-loading Angled Lateral Connector, 25mm
SPINECRAFT, LLC
A3L-OSA25
Not in Commercial Distribution

  • 00193082083334 ()
  • M824A3LOSA251 ()
A3L-OSA25

  • Bone-screw internal spinal fixation system connector
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