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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 - M824A3ZR409325K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-409-325K
In Commercial Distribution

  • 00193082083594 ()
  • M824A3ZR409325K1 ()
A3ZR-409-325K

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

ASTRA-OCT Spine System - M824A3ZR4093251

ASTRA-OCT Dia. 4mm Ti Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-409-325
In Commercial Distribution

  • 00193082083471 ()
  • M824A3ZR4093251 ()
A3ZR-409-325

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

ASTRA-OCT Spine System - M824A3ZR409200K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 9mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-409-200K
In Commercial Distribution

  • 00193082083587 ()
  • M824A3ZR409200K1 ()
A3ZR-409-200K

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

ASTRA-OCT Spine System - M824A3ZR4092001

ASTRA-OCT Dia. 4mm Ti Z-Rod, 9mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-409-200
In Commercial Distribution

  • 00193082083464 ()
  • M824A3ZR4092001 ()
A3ZR-409-200

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

ASTRA-OCT Spine System - M824A3ZR409100K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 9mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-409-100K
In Commercial Distribution

  • 00193082083570 ()
  • M824A3ZR409100K1 ()
A3ZR-409-100K

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

ASTRA-OCT Spine System - M824A3ZR4091001

ASTRA-OCT Dia. 4mm Ti Z-Rod, 9mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-409-100
In Commercial Distribution

  • 00193082083457 ()
  • M824A3ZR4091001 ()
A3ZR-409-100

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

ASTRA-OCT Spine System - M824A3ZR407325K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 7mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-407-325K
In Commercial Distribution

  • 00193082083563 ()
  • M824A3ZR407325K1 ()
A3ZR-407-325K

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

ASTRA-OCT Spine System - M824A3ZR4073251

ASTRA-OCT Dia. 4mm Ti Z-Rod, 7mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-407-325
In Commercial Distribution

  • 00193082083440 ()
  • M824A3ZR4073251 ()
A3ZR-407-325

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

ASTRA-OCT Spine System - M824A3ZR407200K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 7mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-407-200K
In Commercial Distribution

  • 00193082083556 ()
  • M824A3ZR407200K1 ()
A3ZR-407-200K

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

ASTRA-OCT Spine System - M824A3ZR4072001

ASTRA-OCT Dia. 4mm Ti Z-Rod, 7mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-407-200
In Commercial Distribution

  • 00193082083433 ()
  • M824A3ZR4072001 ()
A3ZR-407-200

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

ASTRA-OCT Spine System - M824A3ZR407100K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-407-100K
In Commercial Distribution

  • 00193082083549 ()
  • M824A3ZR407100K1 ()
A3ZR-407-100K

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

ASTRA-OCT Spine System - M824A3ZR4071001

ASTRA-OCT Dia. 4mm Ti Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-407-100
In Commercial Distribution

  • 00193082083426 ()
  • M824A3ZR4071001 ()
A3ZR-407-100

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

ASTRA-OCT Spine System - M824A3ZR359325K1

ASTRA-OCT Dia. 3.5mm CoCr Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-359-325K
In Commercial Distribution

  • 00193082083532 ()
  • M824A3ZR359325K1 ()
A3ZR-359-325K

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

ASTRA-OCT Spine System - M824A3ZR3593251

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-359-325
In Commercial Distribution

  • 00193082083419 ()
  • M824A3ZR3593251 ()
A3ZR-359-325

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

ASTRA-OCT Spine System - M824A3ZR359200K1

ASTRA-OCT Dia. 3.5mm CoCr Z-Rod, 9mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-359-200K
In Commercial Distribution

  • 00193082083525 ()
  • M824A3ZR359200K1 ()
A3ZR-359-200K

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

ASTRA-OCT Spine System - M824A3ZR3592001

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 9mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-359-200
In Commercial Distribution

  • 00193082083402 ()
  • M824A3ZR3592001 ()
A3ZR-359-200

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

ASTRA-OCT Spine System - M824A3ZR3591001

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 9mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-359-100
In Commercial Distribution

  • 00193082083396 ()
  • M824A3ZR3591001 ()
A3ZR-359-100

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

ASTRA-OCT Spine System - M824A3ZR3572001

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 7mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-357-200
In Commercial Distribution

  • 00193082083372 ()
  • M824A3ZR3572001 ()
A3ZR-357-200

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

ASTRA-OCT Spine System - M824A3ZR357100K1

ASTRA-OCT Dia. 3.5mm CoCr Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-357-100K
In Commercial Distribution

  • 00193082083488 ()
  • M824A3ZR357100K1 ()
A3ZR-357-100K

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

ASTRA-OCT Spine System - M824A3XS451

ASTRA-OCT Screw-to-Screw Cross Connector, 45mm
SPINECRAFT, LLC
A3X-S45
In Commercial Distribution

  • 00193082083037 ()
  • M824A3XS451 ()
A3X-S45

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

ASTRA-OCT Spine System - M824A3XS411

ASTRA-OCT Screw-to-Screw Cross Connector, 41mm
SPINECRAFT, LLC
A3X-S41
In Commercial Distribution

  • 00193082083020 ()
  • M824A3XS411 ()
A3X-S41

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

ASTRA-OCT Spine System - M824A3XS371

ASTRA-OCT Screw-to-Screw Cross Connector, 37mm
SPINECRAFT, LLC
A3X-S37
In Commercial Distribution

  • 00193082083013 ()
  • M824A3XS371 ()
A3X-S37

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

ASTRA-OCT Spine System - M824A3XS331

ASTRA-OCT Screw-to-Screw Cross Connector, 33mm
SPINECRAFT, LLC
A3X-S33
In Commercial Distribution

  • 00193082083006 ()
  • M824A3XS331 ()
A3X-S33

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

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
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