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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 - M824A3P45121

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 12mm
SPINECRAFT, LLC
A3P-4512
Not in Commercial Distribution

  • 00193082079832 ()
  • M824A3P45121 ()
A3P-4512

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4510R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 10mm
SPINECRAFT, LLC
A3P-4510R
Not in Commercial Distribution

  • 00193082080616 ()
  • M824A3P4510R1 ()
A3P-4510R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45101

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 10mm
SPINECRAFT, LLC
A3P-4510
Not in Commercial Distribution

  • 00193082079825 ()
  • M824A3P45101 ()
A3P-4510

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4050S1

ASTRA-OCT Dia. 4.0mm Polyaxial Smooth Shank Screw, 50mm
SPINECRAFT, LLC
A3P-4050-S
Not in Commercial Distribution

  • 00193082081316 ()
  • M824A3P4050S1 ()
A3P-4050-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4050RS1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Smooth Shank Screw, 50mm
SPINECRAFT, LLC
A3P-4050R-S
Not in Commercial Distribution

  • 00193082081651 ()
  • M824A3P4050RS1 ()
A3P-4050R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4050R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-4050R
Not in Commercial Distribution

  • 00193082080609 ()
  • M824A3P4050R1 ()
A3P-4050R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40501

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 50mm
SPINECRAFT, LLC
A3P-4050
Not in Commercial Distribution

  • 00193082079818 ()
  • M824A3P40501 ()
A3P-4050

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4048S1

ASTRA-OCT Dia. 4.0mm Polyaxial Smooth Shank Screw, 48mm
SPINECRAFT, LLC
A3P-4048-S
Not in Commercial Distribution

  • 00193082081309 ()
  • M824A3P4048S1 ()
A3P-4048-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4048RS1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Smooth Shank Screw, 48mm
SPINECRAFT, LLC
A3P-4048R-S
Not in Commercial Distribution

  • 00193082081644 ()
  • M824A3P4048RS1 ()
A3P-4048R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4046S1

ASTRA-OCT Dia. 4.0mm Polyaxial Smooth Shank Screw, 46mm
SPINECRAFT, LLC
A3P-4046-S
Not in Commercial Distribution

  • 00193082081293 ()
  • M824A3P4046S1 ()
A3P-4046-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4046R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 46mm
SPINECRAFT, LLC
A3P-4046R
Not in Commercial Distribution

  • 00193082080586 ()
  • M824A3P4046R1 ()
A3P-4046R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4044S1

ASTRA-OCT Dia. 4.0mm Polyaxial Smooth Shank Screw, 44mm
SPINECRAFT, LLC
A3P-4044-S
Not in Commercial Distribution

  • 00193082081286 ()
  • M824A3P4044S1 ()
A3P-4044-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4044R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 44mm
SPINECRAFT, LLC
A3P-4044R
Not in Commercial Distribution

  • 00193082080579 ()
  • M824A3P4044R1 ()
A3P-4044R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4042S1

ASTRA-OCT Dia. 4.0mm Polyaxial Smooth Shank Screw, 42mm
SPINECRAFT, LLC
A3P-4042-S
Not in Commercial Distribution

  • 00193082081279 ()
  • M824A3P4042S1 ()
A3P-4042-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4042R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 42mm
SPINECRAFT, LLC
A3P-4042R
Not in Commercial Distribution

  • 00193082080562 ()
  • M824A3P4042R1 ()
A3P-4042R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4040S1

ASTRA-OCT Dia. 4.0mm Polyaxial Smooth Shank Screw, 40mm
SPINECRAFT, LLC
A3P-4040-S
Not in Commercial Distribution

  • 00193082081262 ()
  • M824A3P4040S1 ()
A3P-4040-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4024R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 24mm
SPINECRAFT, LLC
A3P-4024R
Not in Commercial Distribution

  • 00193082080470 ()
  • M824A3P4024R1 ()
A3P-4024R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40241

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 24mm
SPINECRAFT, LLC
A3P-4024
Not in Commercial Distribution

  • 00193082079689 ()
  • M824A3P40241 ()
A3P-4024

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4022S1

ASTRA-OCT Dia. 4.0mm Polyaxial Smooth Shank Screw, 22mm
SPINECRAFT, LLC
A3P-4022-S
Not in Commercial Distribution

  • 00193082081170 ()
  • M824A3P4022S1 ()
A3P-4022-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4022RS1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Smooth Shank Screw, 22mm
SPINECRAFT, LLC
A3P-4022R-S
Not in Commercial Distribution

  • 00193082081514 ()
  • M824A3P4022RS1 ()
A3P-4022R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4022R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 22mm
SPINECRAFT, LLC
A3P-4022R
Not in Commercial Distribution

  • 00193082080463 ()
  • M824A3P4022R1 ()
A3P-4022R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35301

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 30mm
SPINECRAFT, LLC
A3P-3530
Not in Commercial Distribution

  • 00193082079504 ()
  • M824A3P35301 ()
A3P-3530

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3528RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 28mm
SPINECRAFT, LLC
A3P-3528R-S
Not in Commercial Distribution

  • 00193082081378 ()
  • M824A3P3528RS1 ()
A3P-3528R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3528R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 28mm
SPINECRAFT, LLC
A3P-3528R
Not in Commercial Distribution

  • 00193082080289 ()
  • M824A3P3528R1 ()
A3P-3528R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3526S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 26mm
SPINECRAFT, LLC
A3P-3526-S
Not in Commercial Distribution

  • 00193082081026 ()
  • M824A3P3526S1 ()
A3P-3526-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3526R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 26mm
SPINECRAFT, LLC
A3P-3526R
Not in Commercial Distribution

  • 00193082080272 ()
  • M824A3P3526R1 ()
A3P-3526R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3524S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 24mm
SPINECRAFT, LLC
A3P-3524-S
Not in Commercial Distribution

  • 00193082081019 ()
  • M824A3P3524S1 ()
A3P-3524-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3524R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 24mm
SPINECRAFT, LLC
A3P-3524R
Not in Commercial Distribution

  • 00193082080265 ()
  • M824A3P3524R1 ()
A3P-3524R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3522S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 22mm
SPINECRAFT, LLC
A3P-3522-S
Not in Commercial Distribution

  • 00193082081002 ()
  • M824A3P3522S1 ()
A3P-3522-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3522R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 22mm
SPINECRAFT, LLC
A3P-3522R
Not in Commercial Distribution

  • 00193082080258 ()
  • M824A3P3522R1 ()
A3P-3522R

  • Spinal bone screw, non-bioabsorbable
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