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, POLYAXIAL, NON-FLUTED
Pioneer Surgical Technology, Inc.
10-675-PAT-35
Not in Commercial Distribution


  • 6.75mm (D) X 35mm (L)
10-675-PAT-35

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-675-PA-90
Not in Commercial Distribution


  • 6.75mm (D) X 90mm (L)
10-675-PA-90

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-675-PA-80
Not in Commercial Distribution


  • 6.75mm (D) X 80mm (L)
10-675-PA-80

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-675-PA-30
Not in Commercial Distribution


  • 6.75mm (D) X 30mm (L)
10-675-PA-30

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-675-FX-50
Not in Commercial Distribution


  • 6.75mm (D) X 50mm (L)
10-675-FX-50

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-675-FX-35
Not in Commercial Distribution


  • 6.75mm (D) X 35mm (L)
10-675-FX-35

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-675-FX-30
Not in Commercial Distribution


  • 6.75mm (D) X 30mm (L)
10-675-FX-30

  • Bone-screw internal spinal fixation system, non-sterile
ROD CONNECTOR, OPEN, PARALLEL
Pioneer Surgical Technology, Inc.
10-635-RCOP-5
Not in Commercial Distribution

  • 00846468089542 ()
10-635-RCOP-5

  • Orthopaedic prosthesis implantation positioning instrument, reusable
ROD CONNECTOR, OPEN, PARALLEL
Pioneer Surgical Technology, Inc.
10-60-RCOP-5
Not in Commercial Distribution

  • 00846468089535 ()
10-60-RCOP-5

  • Orthopaedic prosthesis implantation positioning instrument, reusable
X-LINK, VARIABLE
Pioneer Surgical Technology, Inc.
10-6070-VXL
Not in Commercial Distribution


  • 60mm - 70mm
10-6070-VXL

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