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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 - M824A3OS45101

ASTRA-OCT Dia. 4.5mm Occipital Bone Screw, 10mm
SPINECRAFT, LLC
A3OS-4510
Not in Commercial Distribution

  • 00193082083662 ()
  • M824A3OS45101 ()
A3OS-4510

  • 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 - M824A3OR409030K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 300mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-40-9030K
Not in Commercial Distribution

  • 00193082082801 ()
  • M824A3OR409030K1 ()
A3OR-40-9030K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR409020K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 200mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-40-9020K
Not in Commercial Distribution

  • 00193082082795 ()
  • M824A3OR409020K1 ()
A3OR-40-9020K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR407532K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 325mm x 75deg (105deg)
SPINECRAFT, LLC
A3OR-40-7532K
Not in Commercial Distribution

  • 00193082082788 ()
  • M824A3OR407532K1 ()
A3OR-40-7532K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR407530K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 300mm x 75deg (105deg)
SPINECRAFT, LLC
A3OR-40-7530K
Not in Commercial Distribution

  • 00193082082771 ()
  • M824A3OR407530K1 ()
A3OR-40-7530K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR4075301

ASTRA-OCT Dia. 4mm Ti Occipital Rod, 300mm x 75deg (105deg)
SPINECRAFT, LLC
A3OR-40-7530
Not in Commercial Distribution

  • 00193082082191 ()
  • M824A3OR4075301 ()
A3OR-40-7530

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR406032K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 325mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-40-6032K
Not in Commercial Distribution

  • 00193082082757 ()
  • M824A3OR406032K1 ()
A3OR-40-6032K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR4060321

ASTRA-OCT Dia. 4mm Ti Occipital Rod, 325mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-40-6032
Not in Commercial Distribution

  • 00193082082177 ()
  • M824A3OR4060321 ()
A3OR-40-6032

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR4060301

ASTRA-OCT Dia. 4mm Ti Occipital Rod, 300mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-40-6030
Not in Commercial Distribution

  • 00193082082160 ()
  • M824A3OR4060301 ()
A3OR-40-6030

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR4060201

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

  • 00193082082153 ()
  • M824A3OR4060201 ()
A3OR-40-6020

  • 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 - M824A3OR3590301

ASTRA-OCT Dia. 3.5mm Ti Occipital Rod, 300mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-35-9030
Not in Commercial Distribution

  • 00193082081934 ()
  • M824A3OR3590301 ()
A3OR-35-9030

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR3590201

ASTRA-OCT Dia. 3.5mm Ti Occipital Rod, 200mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-35-9020
Not in Commercial Distribution

  • 00193082081927 ()
  • M824A3OR3590201 ()
A3OR-35-9020

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR357532K1

ASTRA-OCT Dia. 3.5mm CoCr Occipital Rod, 325mm x 75deg (105deg)
SPINECRAFT, LLC
A3OR-35-7532K
Not in Commercial Distribution

  • 00193082082498 ()
  • M824A3OR357532K1 ()
A3OR-35-7532K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR357530K1

ASTRA-OCT Dia. 3.5mm CoCr Occipital Rod, 300mm x 75deg (105deg)
SPINECRAFT, LLC
A3OR-35-7530K
Not in Commercial Distribution

  • 00193082082481 ()
  • M824A3OR357530K1 ()
A3OR-35-7530K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR357520K1

ASTRA-OCT Dia. 3.5mm CoCr Occipital Rod, 200mm x 75deg (105deg)
SPINECRAFT, LLC
A3OR-35-7520K
Not in Commercial Distribution

  • 00193082082474 ()
  • M824A3OR357520K1 ()
A3OR-35-7520K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR356032K1

ASTRA-OCT Dia. 3.5mm CoCr Occipital Rod, 325mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-35-6032K
Not in Commercial Distribution

  • 00193082082467 ()
  • M824A3OR356032K1 ()
A3OR-35-6032K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR356030K1

ASTRA-OCT Dia. 3.5mm CoCr Occipital Rod, 300mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-35-6030K
Not in Commercial Distribution

  • 00193082082450 ()
  • M824A3OR356030K1 ()
A3OR-35-6030K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR3560301

ASTRA-OCT Dia. 3.5mm Ti Occipital Rod, 300mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-35-6030
Not in Commercial Distribution

  • 00193082081873 ()
  • M824A3OR3560301 ()
A3OR-35-6030

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3OR3560201

ASTRA-OCT Dia. 3.5mm Ti Occipital Rod, 200mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-35-6020
Not in Commercial Distribution

  • 00193082081866 ()
  • M824A3OR3560201 ()
A3OR-35-6020

  • 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 - 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 - M824A3LOSA151

ASTRA-OCT Open Side-loading Angled Lateral Connector, 15mm
SPINECRAFT, LLC
A3L-OSA15
Not in Commercial Distribution

  • 00193082083310 ()
  • M824A3LOSA151 ()
A3L-OSA15

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3LOS251

ASTRA-OCT Open Side-loading Lateral Connector, 25mm
SPINECRAFT, LLC
A3L-OS25
Not in Commercial Distribution

  • 00193082083297 ()
  • M824A3LOS251 ()
A3L-OS25

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3LOS151

ASTRA-OCT Open Side-loading Lateral Connector, 15mm
SPINECRAFT, LLC
A3L-OS15
Not in Commercial Distribution

  • 00193082083273 ()
  • M824A3LOS151 ()
A3L-OS15

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3LC251

ASTRA-OCT Closed Lateral Connector, 25mm
SPINECRAFT, LLC
A3L-C25
Not in Commercial Distribution

  • 00193082083259 ()
  • M824A3LC251 ()
A3L-C25

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3LC201

ASTRA-OCT Closed Lateral Connector, 20mm
SPINECRAFT, LLC
A3L-C20
Not in Commercial Distribution

  • 00193082083242 ()
  • M824A3LC201 ()
A3L-C20

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3HRO651

ASTRA-OCT Right Offset Hook, 6.5mm
SPINECRAFT, LLC
A3H-RO65
Not in Commercial Distribution

  • 00193082082962 ()
  • M824A3HRO651 ()
A3H-RO65

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HRO551

ASTRA-OCT Right Offset Hook, 5.5mm
SPINECRAFT, LLC
A3H-RO55
Not in Commercial Distribution

  • 00193082082955 ()
  • M824A3HRO551 ()
A3H-RO55

  • Bone-screw internal spinal fixation system hook
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