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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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APEX Spine System - M824U670801

Uniplanar Pedicle Screw, 7.00mm x 80mm
SPINECRAFT, LLC
U6-7080
In Commercial Distribution

  • M824U670801 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67070C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 70mm
SPINECRAFT, LLC
U6-7070C
In Commercial Distribution

  • M824U67070C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670701

Uniplanar Pedicle Screw, 7.00mm x 70mm
SPINECRAFT, LLC
U6-7070
In Commercial Distribution

  • M824U670701 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67060C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 60mm
SPINECRAFT, LLC
U6-7060C
In Commercial Distribution

  • M824U67060C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670601

Uniplanar Pedicle Screw, 7.00mm x 60mm
SPINECRAFT, LLC
U6-7060
In Commercial Distribution

  • M824U670601 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67055C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 55mm
SPINECRAFT, LLC
U6-7055C
In Commercial Distribution

  • M824U67055C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670551

Uniplanar Pedicle Screw, 7.00mm x 55mm
SPINECRAFT, LLC
U6-7055
In Commercial Distribution

  • M824U670551 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67050C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 50mm
SPINECRAFT, LLC
U6-7050C
In Commercial Distribution

  • M824U67050C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670501

Uniplanar Pedicle Screw, 7.00mm x 50mm
SPINECRAFT, LLC
U6-7050
In Commercial Distribution

  • M824U670501 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67045C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 45mm
SPINECRAFT, LLC
U6-7045C
In Commercial Distribution

  • M824U67045C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670451

Uniplanar Pedicle Screw, 7.00mm x 45mm
SPINECRAFT, LLC
U6-7045
In Commercial Distribution

  • M824U670451 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67040C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 40mm
SPINECRAFT, LLC
U6-7040C
In Commercial Distribution

  • M824U67040C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670401

Uniplanar Pedicle Screw, 7.00mm x 40mm
SPINECRAFT, LLC
U6-7040
In Commercial Distribution

  • M824U670401 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67035C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 35mm
SPINECRAFT, LLC
U6-7035C
In Commercial Distribution

  • M824U67035C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670351

Uniplanar Pedicle Screw, 7.00mm x 35mm
SPINECRAFT, LLC
U6-7035
In Commercial Distribution

  • M824U670351 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67030C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 30mm
SPINECRAFT, LLC
U6-7030C
In Commercial Distribution

  • M824U67030C1 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U670301

Uniplanar Pedicle Screw, 7.00mm x 30mm
SPINECRAFT, LLC
U6-7030
In Commercial Distribution

  • M824U670301 ()


  • Bone-screw internal spinal fixation system

APEX Spine System - M824U67025C1

Cannulated Uniplanar Pedicle Screw, 7.00mm x 25mm
SPINECRAFT, LLC
U6-7025C
In Commercial Distribution

  • M824U67025C1 ()


  • Bone-screw internal spinal fixation system

ASTRA Spine System - M824A5P9560C1

ASTRA Ti Cannulated Polyaxial Screw 9.50 x 60mm
SPINECRAFT, LLC
A5P-9560-C
In Commercial Distribution

  • M824A5P9560C1 ()


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

ASTRA Spine System - M824A5P95601

ASTRA Ti Polyaxial Screw 9.50 x 60mm
SPINECRAFT, LLC
A5P-9560
In Commercial Distribution

  • M824A5P95601 ()


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

ASTRA Spine System - M824A5P9555RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 9.50 x 55mm
SPINECRAFT, LLC
A5P-9555R-C
In Commercial Distribution

  • M824A5P9555RC1 ()


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

ASTRA Spine System - M824A5P9555R1

ASTRA Ti Polyaxial Reduction Screw 9.50 x 55mm
SPINECRAFT, LLC
A5P-9555R
In Commercial Distribution

  • M824A5P9555R1 ()


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

ASTRA Spine System - M824A5P9555C1

ASTRA Ti Cannulated Polyaxial Screw 9.50 x 55mm
SPINECRAFT, LLC
A5P-9555-C
In Commercial Distribution

  • M824A5P9555C1 ()


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

ASTRA Spine System - M824A5P95551

ASTRA Ti Polyaxial Screw 9.50 x 55mm
SPINECRAFT, LLC
A5P-9555
In Commercial Distribution

  • M824A5P95551 ()


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

ASTRA Spine System - M824A5P9550RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 9.50 x 50mm
SPINECRAFT, LLC
A5P-9550R-C
In Commercial Distribution

  • M824A5P9550RC1 ()


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

ASTRA Spine System - M824A5P9550R1

ASTRA Ti Polyaxial Reduction Screw 9.50 x 50mm
SPINECRAFT, LLC
A5P-9550R
In Commercial Distribution

  • M824A5P9550R1 ()


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

ASTRA Spine System - M824A5P9550C1

ASTRA Ti Cannulated Polyaxial Screw 9.50 x 50mm
SPINECRAFT, LLC
A5P-9550-C
In Commercial Distribution

  • M824A5P9550C1 ()


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

ASTRA Spine System - M824A5P95501

ASTRA Ti Polyaxial Screw 9.50 x 50mm
SPINECRAFT, LLC
A5P-9550
In Commercial Distribution

  • M824A5P95501 ()


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

ASTRA Spine System - M824A5P9545RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 9.50 x 45mm
SPINECRAFT, LLC
A5P-9545R-C
In Commercial Distribution

  • M824A5P9545RC1 ()


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

ASTRA Spine System - M824A5P9545R1

ASTRA Ti Polyaxial Reduction Screw 9.50 x 45mm
SPINECRAFT, LLC
A5P-9545R
In Commercial Distribution

  • M824A5P9545R1 ()


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