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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 - M824A3XR39491

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 39-49mm
SPINECRAFT, LLC
A3X-R3949
In Commercial Distribution

  • 00193082082993 ()
  • M824A3XR39491 ()
A3X-R3949

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XR35401

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 35-40mm
SPINECRAFT, LLC
A3X-R3540
In Commercial Distribution

  • 00193082082986 ()
  • M824A3XR35401 ()
A3X-R3540

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XR31351

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 31-35mm
SPINECRAFT, LLC
A3X-R3135
In Commercial Distribution

  • 00193082082979 ()
  • M824A3XR31351 ()
A3X-R3135

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3TC55281

ASTRA-OCT Tandem Connector, 28mm, fitting Dia. 5.5/6.0mm (4 screw)
SPINECRAFT, LLC
A3T-C55-28
In Commercial Distribution

  • 00193082083167 ()
  • M824A3TC55281 ()
A3T-C55-28

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3TC55151

ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 5.5/6.0mm (2 screw)
SPINECRAFT, LLC
A3T-C55-15
In Commercial Distribution

  • 00193082083136 ()
  • M824A3TC55151 ()
A3T-C55-15

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3TC45281

ASTRA-OCT Tandem Connector, 28mm, fitting Dia. 4.5/Dia. 5.0mm (4 screw)
SPINECRAFT, LLC
A3T-C45-28
In Commercial Distribution

  • 00193082083150 ()
  • M824A3TC45281 ()
A3T-C45-28

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3TC45151

ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 4.5/Dia. 5.0mm (2 screw)
SPINECRAFT, LLC
A3T-C45-15
In Commercial Distribution

  • 00193082083129 ()
  • M824A3TC45151 ()
A3T-C45-15

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3TC35281

ASTRA-OCT Tandem Connector, 28mm, fitting Dia. 3.5/Dia. 4.0mm (4 screw)
SPINECRAFT, LLC
A3T-C35-28
In Commercial Distribution

  • 00193082083143 ()
  • M824A3TC35281 ()
A3T-C35-28

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3TC35151

ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 3.5/Dia. 4.0mm (2 screw)
SPINECRAFT, LLC
A3T-C35-15
In Commercial Distribution

  • 00193082083112 ()
  • M824A3TC35151 ()
A3T-C35-15

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3SXT151

ASTRA-OCT Screw-to-Screw Cross Connector T15 Set Screw
SPINECRAFT, LLC
A3S-XT15
In Commercial Distribution

  • 00193082083211 ()
  • M824A3SXT151 ()
A3S-XT15

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3SXN1

ASTRA-OCT Cross Connector Nut
SPINECRAFT, LLC
A3S-XN
In Commercial Distribution

  • 00193082083204 ()
  • M824A3SXN1 ()
A3S-XN

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3ST15F1

ASTRA-OCT T15 Set Screw, Flat
SPINECRAFT, LLC
A3S-T15F
In Commercial Distribution

  • 00193082083198 ()
  • M824A3ST15F1 ()
A3S-T15F

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3ST15C1

ASTRA-OCT T15 Set Screw, Coned
SPINECRAFT, LLC
A3S-T15C
In Commercial Distribution

  • 00193082083181 ()
  • M824A3ST15C1 ()
A3S-T15C

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3ST151

ASTRA-OCT T15 Set Screw
SPINECRAFT, LLC
A3S-T15
In Commercial Distribution

  • 00193082083174 ()
  • M824A3ST151 ()
A3S-T15

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT45500K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T45-500K
In Commercial Distribution

  • 00193082082726 ()
  • M824A3RT45500K1 ()
A3R-T45-500K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT455001

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T45-500
In Commercial Distribution

  • 00193082082146 ()
  • M824A3RT455001 ()
A3R-T45-500

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT45325K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325K
In Commercial Distribution

  • 00193082082719 ()
  • M824A3RT45325K1 ()
A3R-T45-325K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT453251

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325
In Commercial Distribution

  • 00193082082139 ()
  • M824A3RT453251 ()
A3R-T45-325

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT44500K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500K
In Commercial Distribution

  • 00193082082702 ()
  • M824A3RT44500K1 ()
A3R-T44-500K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT445001

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500
In Commercial Distribution

  • 00193082082122 ()
  • M824A3RT445001 ()
A3R-T44-500

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT44325K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325K
In Commercial Distribution

  • 00193082082696 ()
  • M824A3RT44325K1 ()
A3R-T44-325K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT443251

ASTRA-OCT Dia. 4mm Ti Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325
In Commercial Distribution

  • 00193082082115 ()
  • M824A3RT443251 ()
A3R-T44-325

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT35500K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500K
In Commercial Distribution

  • 00193082082436 ()
  • M824A3RT35500K1 ()
A3R-T35-500K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT355001

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500
In Commercial Distribution

  • 00193082081859 ()
  • M824A3RT355001 ()
A3R-T35-500

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT35325K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325K
In Commercial Distribution

  • 00193082082429 ()
  • M824A3RT35325K1 ()
A3R-T35-325K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT353251

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325
In Commercial Distribution

  • 00193082081842 ()
  • M824A3RT353251 ()
A3R-T35-325

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT34500K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T34-500K
In Commercial Distribution

  • 00193082082412 ()
  • M824A3RT34500K1 ()
A3R-T34-500K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT345001

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T34-500
In Commercial Distribution

  • 00193082081835 ()
  • M824A3RT345001 ()
A3R-T34-500

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT34325K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T34-325K
In Commercial Distribution

  • 00193082082405 ()
  • M824A3RT34325K1 ()
A3R-T34-325K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3RT343251

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T34-325
In Commercial Distribution

  • 00193082081828 ()
  • M824A3RT343251 ()
A3R-T34-325

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40450K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 450mm
SPINECRAFT, LLC
A3R-40-450K
In Commercial Distribution

  • 00193082082689 ()
  • M824A3R40450K1 ()
A3R-40-450K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R404501

ASTRA-OCT Dia. 4mm Ti Straight Rod, 450mm
SPINECRAFT, LLC
A3R-40-450
In Commercial Distribution

  • 00193082082108 ()
  • M824A3R404501 ()
A3R-40-450

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40325K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 325mm
SPINECRAFT, LLC
A3R-40-325K
In Commercial Distribution

  • 00193082082672 ()
  • M824A3R40325K1 ()
A3R-40-325K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R403251

ASTRA-OCT Dia. 4mm Ti Straight Rod, 325mm
SPINECRAFT, LLC
A3R-40-325
In Commercial Distribution

  • 00193082082092 ()
  • M824A3R403251 ()
A3R-40-325

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40300K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 300mm
SPINECRAFT, LLC
A3R-40-300K
In Commercial Distribution

  • 00193082082665 ()
  • M824A3R40300K1 ()
A3R-40-300K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R403001

ASTRA-OCT Dia. 4mm Ti Straight Rod, 300mm
SPINECRAFT, LLC
A3R-40-300
In Commercial Distribution

  • 00193082082085 ()
  • M824A3R403001 ()
A3R-40-300

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40200K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 200mm
SPINECRAFT, LLC
A3R-40-200K
In Commercial Distribution

  • 00193082082658 ()
  • M824A3R40200K1 ()
A3R-40-200K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R402001

ASTRA-OCT Dia. 4mm Ti Straight Rod, 200mm
SPINECRAFT, LLC
A3R-40-200
In Commercial Distribution

  • 00193082082078 ()
  • M824A3R402001 ()
A3R-40-200

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40100K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 100mm
SPINECRAFT, LLC
A3R-40-100K
In Commercial Distribution

  • 00193082082641 ()
  • M824A3R40100K1 ()
A3R-40-100K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R401001

ASTRA-OCT Dia. 4mm Ti Straight Rod, 100mm
SPINECRAFT, LLC
A3R-40-100
In Commercial Distribution

  • 00193082082061 ()
  • M824A3R401001 ()
A3R-40-100

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40090K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 90mm
SPINECRAFT, LLC
A3R-40-090K
In Commercial Distribution

  • 00193082082634 ()
  • M824A3R40090K1 ()
A3R-40-090K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R400901

ASTRA-OCT Dia. 4mm Ti Straight Rod, 90mm
SPINECRAFT, LLC
A3R-40-090
In Commercial Distribution

  • 00193082082054 ()
  • M824A3R400901 ()
A3R-40-090

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40080K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 80mm
SPINECRAFT, LLC
A3R-40-080K
In Commercial Distribution

  • 00193082082627 ()
  • M824A3R40080K1 ()
A3R-40-080K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R400801

ASTRA-OCT Dia. 4mm Ti Straight Rod, 80mm
SPINECRAFT, LLC
A3R-40-080
In Commercial Distribution

  • 00193082082047 ()
  • M824A3R400801 ()
A3R-40-080

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40070K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 70mm
SPINECRAFT, LLC
A3R-40-070K
In Commercial Distribution

  • 00193082082610 ()
  • M824A3R40070K1 ()
A3R-40-070K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R400701

ASTRA-OCT Dia. 4mm Ti Straight Rod, 70mm
SPINECRAFT, LLC
A3R-40-070
In Commercial Distribution

  • 00193082082030 ()
  • M824A3R400701 ()
A3R-40-070

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40060K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 60mm
SPINECRAFT, LLC
A3R-40-060K
In Commercial Distribution

  • 00193082082603 ()
  • M824A3R40060K1 ()
A3R-40-060K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R400601

ASTRA-OCT Dia. 4mm Ti Straight Rod, 60mm
SPINECRAFT, LLC
A3R-40-060
In Commercial Distribution

  • 00193082082023 ()
  • M824A3R400601 ()
A3R-40-060

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R40050K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 50mm
SPINECRAFT, LLC
A3R-40-050K
In Commercial Distribution

  • 00193082082597 ()
  • M824A3R40050K1 ()
A3R-40-050K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R400501

ASTRA-OCT Dia. 4mm Ti Straight Rod, 50mm
SPINECRAFT, LLC
A3R-40-050
In Commercial Distribution

  • 00193082082016 ()
  • M824A3R400501 ()
A3R-40-050

  • Bone-screw internal spinal fixation system, non-sterile
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