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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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APEX-DL Spine System - M8245500045ML1

Ti MIS Rod 5.50 x 45mm, Lordosed
SPINECRAFT, LLC
5500-045ML
In Commercial Distribution

  • M8245500045ML1 ()


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

APEX-DL Spine System - M8245500040ML1

Ti MIS Rod 5.50 x 40mm, Lordosed
SPINECRAFT, LLC
5500-040ML
In Commercial Distribution

  • M8245500040ML1 ()


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

ASTRA Spine System - M824A5R55MF045COCR1

5.5mm CoCr MIS Fixed Straight Rod, 45mm
SPINECRAFT, LLC
A5R-55MF-045-CoCr
In Commercial Distribution

  • M824A5R55MF045COCR1 ()


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

ASTRA Spine System - M824A5R55MF040COCR1

5.5mm CoCr MIS Fixed Straight Rod, 40mm
SPINECRAFT, LLC
A5R-55MF-040-CoCr
In Commercial Distribution

  • M824A5R55MF040COCR1 ()


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

ASTRA Spine System - M824A5R55MF0351

5.5mm Ti MIS Fixed Straight Rod, 35mm
SPINECRAFT, LLC
A5R-55MF-035
In Commercial Distribution

  • M824A5R55MF0351 ()


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

ASTRA Spine System - M824A5R55MF030COCR1

5.5mm CoCr MIS Fixed Straight Rod, 30mm
SPINECRAFT, LLC
A5R-55MF-030-CoCr
In Commercial Distribution

  • M824A5R55MF030COCR1 ()


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

ASTRA Spine System - M824A5R55MF025COCR1

5.5mm CoCr MIS Fixed Straight Rod, 25mm
SPINECRAFT, LLC
A5R-55MF-025-CoCr
In Commercial Distribution

  • M824A5R55MF025COCR1 ()


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

ASTRA Spine System - M824A5R55L0901

5.5mm Ti Lordosed Rod, 90mm
SPINECRAFT, LLC
A5R-55L-090
In Commercial Distribution

  • M824A5R55L0901 ()


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

ASTRA Spine System - M824A5R55L080K1

ASTRA 5.5mm CoCr Lordosed Rod, 80mm
SPINECRAFT, LLC
A5R-55L-080K
In Commercial Distribution

  • M824A5R55L080K1 ()
A5R-55L-080K

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

ASTRA Spine System - M824A5R55L0801

5.5mm Ti Lordosed Rod, 80mm
SPINECRAFT, LLC
A5R-55L-080
In Commercial Distribution

  • M824A5R55L0801 ()


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