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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 - 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 - M824A3OR356020K1

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

  • 00193082082443 ()
  • M824A3OR356020K1 ()
A3OR-35-6020K

  • 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 - M824A3OPA481

ASTRA-OCT Adjustable Occipital Plate, 48mm
SPINECRAFT, LLC
A3OP-A48
Not in Commercial Distribution

  • 00193082083631 ()
  • M824A3OPA481 ()
A3OP-A48

  • Spinal fixation plate, non-bioabsorbable

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 - M824A3OPA321

ASTRA-OCT Adjustable Occipital Plate, 32mm
SPINECRAFT, LLC
A3OP-A32
Not in Commercial Distribution

  • 00193082083600 ()
  • M824A3OPA321 ()
A3OP-A32

  • 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

ASTRA-OCT Spine System - M824A3LOSA201

ASTRA-OCT Open Side-loading Angled Lateral Connector, 20mm
SPINECRAFT, LLC
A3L-OSA20
Not in Commercial Distribution

  • 00193082083327 ()
  • M824A3LOSA201 ()
A3L-OSA20

  • Bone-screw internal spinal fixation system connector
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