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

  • 00193082083617 ()
  • M824A3OPA361 ()
A3OP-A36

  • Spinal fixation plate, non-bioabsorbable
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 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 Open Side-loading Lateral Connector, 20mm
SPINECRAFT, LLC
A3L-OS20
Not in Commercial Distribution

  • 00193082083280 ()
  • M824A3LOS201 ()
A3L-OS20

  • Bone-screw internal spinal fixation system connector
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 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 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 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 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 Left Offset Hook, 5.5mm
SPINECRAFT, LLC
A3H-LO55
Not in Commercial Distribution

  • 00193082082924 ()
  • M824A3HLO551 ()
A3H-LO55

  • Bone-screw internal spinal fixation system hook
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