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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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PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-50
Not in Commercial Distribution


  • 4.00mm (D) X 50mm (L)
10-400-FX-50

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-45
Not in Commercial Distribution


  • 4.00mm (D) X 45mm (L)
10-400-FX-45

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-40
Not in Commercial Distribution


  • 4.00mm (D) X 40mm (L)
10-400-FX-40

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-35
Not in Commercial Distribution


  • 4.00mm (D) X 35mm (L)
10-400-FX-35

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-30
Not in Commercial Distribution


  • 4.00mm (D) X 30mm (L)
10-400-FX-30

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-25
Not in Commercial Distribution


  • 4.00mm (D) X 25mm (L)
10-400-FX-25

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-20
Not in Commercial Distribution


  • 4.00mm (D) X 20mm (L)
10-400-FX-20

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-16-FXL
Not in Commercial Distribution


  • 16mm
10-16-FXL

  • Bone-screw internal spinal fixation system, non-sterile
YOKE FORK
Pioneer Surgical Technology, Inc.
10-YOKEFORK
Not in Commercial Distribution

10-YOKEFORK

  • General internal orthopaedic fixation system implantation kit
X-LINK HOLDER
Pioneer Surgical Technology, Inc.
10-XLNKHOLDER
Not in Commercial Distribution

10-XLNKHOLDER

  • General internal orthopaedic fixation system implantation kit
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