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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

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

ASTRA-OCT Spine System - M824A3LOSA101

ASTRA-OCT Open Side-loading Angled Lateral Connector, 10mm
SPINECRAFT, LLC
A3L-OSA10
Not in Commercial Distribution

  • 00193082083303 ()
  • M824A3LOSA101 ()
A3L-OSA10

  • 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 - M824A3LOS101

ASTRA-OCT Open Side-loading Lateral Connector, 10mm
SPINECRAFT, LLC
A3L-OS10
Not in Commercial Distribution

  • 00193082083266 ()
  • M824A3LOS101 ()
A3L-OS10

  • 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 - M824A3LC151

ASTRA-OCT Closed Lateral Connector, 15mm
SPINECRAFT, LLC
A3L-C15
Not in Commercial Distribution

  • 00193082083235 ()
  • M824A3LC151 ()
A3L-C15

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3LC101

ASTRA-OCT Closed Lateral Connector, 10mm
SPINECRAFT, LLC
A3L-C10
Not in Commercial Distribution

  • 00193082083228 ()
  • M824A3LC101 ()
A3L-C10

  • 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

ASTRA-OCT Spine System - M824A3HRO451

ASTRA-OCT Right Offset Hook, 4.5mm
SPINECRAFT, LLC
A3H-RO45
Not in Commercial Distribution

  • 00193082082948 ()
  • M824A3HRO451 ()
A3H-RO45

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HLO651

ASTRA-OCT Left Offset Hook, 6.5mm
SPINECRAFT, LLC
A3H-LO65
Not in Commercial Distribution

  • 00193082082931 ()
  • M824A3HLO651 ()
A3H-LO65

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HLO551

ASTRA-OCT Left Offset Hook, 5.5mm
SPINECRAFT, LLC
A3H-LO55
Not in Commercial Distribution

  • 00193082082924 ()
  • M824A3HLO551 ()
A3H-LO55

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HLO451

ASTRA-OCT Left Offset Hook, 4.5mm
SPINECRAFT, LLC
A3H-LO45
Not in Commercial Distribution

  • 00193082082917 ()
  • M824A3HLO451 ()
A3H-LO45

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HL651

ASTRA-OCT Laminar Hook, 6.5mm
SPINECRAFT, LLC
A3H-L65
Not in Commercial Distribution

  • 00193082082849 ()
  • M824A3HL651 ()
A3H-L65

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HL551

ASTRA-OCT Laminar Hook, 5.5mm
SPINECRAFT, LLC
A3H-L55
Not in Commercial Distribution

  • 00193082082832 ()
  • M824A3HL551 ()
A3H-L55

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HAR651

ASTRA-OCT Angled Right Hook, 6.5mm
SPINECRAFT, LLC
A3H-AR65
Not in Commercial Distribution

  • 00193082082900 ()
  • M824A3HAR651 ()
A3H-AR65

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HAL651

ASTRA-OCT Angled Left Hook, 6.5mm
SPINECRAFT, LLC
A3H-AL65
Not in Commercial Distribution

  • 00193082082870 ()
  • M824A3HAL651 ()
A3H-AL65

  • Bone-screw internal spinal fixation system hook

ASTRA-OCT Spine System - M824A3HAL451

ASTRA-OCT Angled Left Hook, 4.5mm
SPINECRAFT, LLC
A3H-AL45
Not in Commercial Distribution

  • 00193082082856 ()
  • M824A3HAL451 ()
A3H-AL45

  • Bone-screw internal spinal fixation system hook
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