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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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X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-12-FXL
Not in Commercial Distribution

  • 00846468018658 ()
10-12-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-11-FXL
Not in Commercial Distribution

  • 00846468018641 ()
10-11-FXL

  • Bone-screw internal spinal fixation system, non-sterile
ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-RODTEMPLATE
Not in Commercial Distribution

  • 00846468021740 ()


  • General internal orthopaedic fixation system implantation kit
DISTRACTOR, RADIAL, Ø 5.5mm
Pioneer Surgical Technology, Inc.
10-RADIALDIST
Not in Commercial Distribution

  • 00846468021559 ()


  • General internal orthopaedic fixation system implantation kit
COMPRESSOR, RADIAL, Ø 5.5mm
Pioneer Surgical Technology, Inc.
10-RADIALCOMP
Not in Commercial Distribution

  • 00846468021542 ()


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

  • 00846468021535 ()


  • General internal orthopaedic fixation system implantation kit
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5003080-R
Not in Commercial Distribution

  • 00846468021528 ()
10-PJC5003080-R

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

  • 00846468021504 ()
10-PJC5003070-R

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

  • 00846468021481 ()
10-PJC5003060-R

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

  • 00846468021467 ()
10-PJC5003050-R

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