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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 Class Implantable

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ASTRA Spine System - M824A5U6070C1

ASTRA Ti Cannulated Uniplanar Screw 6.00 x 70mm
SPINECRAFT, LLC
A5U-6070-C
In Commercial Distribution

  • M824A5U6070C1 ()


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

ASTRA Spine System - M824A5U60701

ASTRA Ti Uniplanar Screw 6.00 x 70mm
SPINECRAFT, LLC
A5U-6070
In Commercial Distribution

  • M824A5U60701 ()


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

ASTRA Spine System - M824A5U6060RC1

ASTRA Ti Cannulated Uniplanar Reduction Screw 6.00 x 60mm
SPINECRAFT, LLC
A5U-6060R-C
In Commercial Distribution

  • M824A5U6060RC1 ()


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

ASTRA Spine System - M824A5U6060C1

ASTRA Ti Cannulated Uniplanar Screw 6.00 x 60mm
SPINECRAFT, LLC
A5U-6060-C
In Commercial Distribution

  • M824A5U6060C1 ()


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

ASTRA Spine System - M824A5U6055C1

ASTRA Ti Cannulated Uniplanar Screw 6.00 x 55mm
SPINECRAFT, LLC
A5U-6055-C
In Commercial Distribution

  • M824A5U6055C1 ()


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

ASTRA Spine System - M824A5U6050RC1

ASTRA Ti Cannulated Uniplanar Reduction Screw 6.00 x 50mm
SPINECRAFT, LLC
A5U-6050R-C
In Commercial Distribution

  • M824A5U6050RC1 ()


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

APEX-DL Spine System - M824DP685501

APEX-DL Ti Poly Screw 8.50 x 50mm
SPINECRAFT, LLC
DP6-8550
In Commercial Distribution

  • M824DP685501 ()


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

APEX-DL Spine System - M824DP68545C1

APEX-DL Ti Cannulated Poly Screw 8.50 x 45mm
SPINECRAFT, LLC
DP6-8545C
In Commercial Distribution

  • M824DP68545C1 ()


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

APEX-DL Spine System - M824DP685451

APEX-DL Ti Poly Screw 8.50 x 45mm
SPINECRAFT, LLC
DP6-8545
In Commercial Distribution

  • M824DP685451 ()


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

APEX-DL Spine System - M824DP68540C1

APEX-DL Ti Cannulated Poly Screw 8.50 x 40mm
SPINECRAFT, LLC
DP6-8540C
In Commercial Distribution

  • M824DP68540C1 ()


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