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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IN-SITU ROD BENDER, LEFT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-L
Not in Commercial Distribution

10-INSITUBEND-L

  • General internal orthopaedic fixation system implantation kit
SCREW INSERTER
Pioneer Surgical Technology, Inc.
10-INSERTER
Not in Commercial Distribution

10-INSERTER

  • General internal orthopaedic fixation system implantation kit
IMPLANT CASE, LUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE
Not in Commercial Distribution

10-IMPCASE

  • General internal orthopaedic fixation system implantation kit
HOOK HOLDER, ANGLED
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER-A
Not in Commercial Distribution

10-HOOKHOLDER-A

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

10-HOOKHOLDER

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

10-FXLGAGE

  • General internal orthopaedic fixation system implantation kit
CADDY, FIXED SCREW
Pioneer Surgical Technology, Inc.
10-FXCADDY-400
Not in Commercial Distribution


  • 4.00mm
10-FXCADDY-400

  • General internal orthopaedic fixation system implantation kit
FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

10-FINALDRIVER

  • General internal orthopaedic fixation system implantation kit
ELEVATOR, PEDICLE
Pioneer Surgical Technology, Inc.
10-ELEVATOR-P
Not in Commercial Distribution

10-ELEVATOR-P

  • General internal orthopaedic fixation system implantation kit
QSRS, PEDICLE SCREW INSRTR, HUSDON DRIVE
Pioneer Surgical Technology, Inc.
724-980
Not in Commercial Distribution

  • 00846468000165 ()
724-980

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5003080-R
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 80mm
10-PJC5003080-R

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5003080-L
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 80mm
10-PJC5003080-L

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5003070-R
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 70mm
10-PJC5003070-R

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5003070-L
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 70mm
10-PJC5003070-L

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5003060-R
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 60mm
10-PJC5003060-R

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5003060-L
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 60mm
10-PJC5003060-L

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5003050-R
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 50mm
10-PJC5003050-R

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5003050-L
Not in Commercial Distribution


  • 5.5mm X 500mm X 30mm X 50mm
10-PJC5003050-L

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5002070-R
Not in Commercial Distribution


  • 5.5mm X 500mm X 20mm X 70mm
10-PJC5002070-R

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5002070-L
Not in Commercial Distribution


  • 5.5mm X 500mm X 20mm X 70mm
10-PJC5002070-L

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