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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T-HANDLE, RATCHETING
Pioneer Surgical Technology, Inc.
10-RTHANDLE
Not in Commercial Distribution

  • 00846468021795 ()


  • General internal orthopaedic fixation system implantation kit
RATCHETING STRAIGHT HANDLE, 1/4" SDQC
Pioneer Surgical Technology, Inc.
10-RSHANDLE
Not in Commercial Distribution

  • 00846468021788 ()


  • General internal orthopaedic fixation system implantation kit
COUNTER TORQUE WRENCH
Pioneer Surgical Technology, Inc.
10-RR-HANDLE
Not in Commercial Distribution

  • 00846468021771 ()


  • General internal orthopaedic fixation system implantation kit
RATCHETING PALM HANDLE, 1/4" SDQC
Pioneer Surgical Technology, Inc.
10-RPHANDLE
Not in Commercial Distribution

  • 00846468021764 ()


  • General internal orthopaedic fixation system implantation kit
ROD WRENCH, 3/16"
Pioneer Surgical Technology, Inc.
10-RODWRENCH
Not in Commercial Distribution

  • 00846468021757 ()


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

  • 00846468021740 ()


  • General internal orthopaedic fixation system implantation kit
ROD FORCEPS, STRAIGHT, Ø 5.5mm
Pioneer Surgical Technology, Inc.
10-RODFORCEP-S
Not in Commercial Distribution

  • 00846468021733 ()


  • General internal orthopaedic fixation system implantation kit
ROD FORCEPS, 25°, Ø 5.5mm
Pioneer Surgical Technology, Inc.
10-RODFORCEP-25
Not in Commercial Distribution

  • 00846468021726 ()


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

  • 00846468021719 ()


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

  • 00846468021696 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
10-RODCADDY-PR
Not in Commercial Distribution

  • 00846468021689 ()


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

  • 00846468021672 ()


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

  • 00846468021658 ()


  • General internal orthopaedic fixation system implantation kit
X-LINK™ REMOVAL WRENCH
Pioneer Surgical Technology, Inc.
10-REMWRENCH
Not in Commercial Distribution

  • 00846468021627 ()


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

  • 00846468021610 ()


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

  • 00846468021603 ()
10-RCPM

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

  • 00846468021597 ()
10-RCP

  • Bone-screw internal spinal fixation system, non-sterile
ROD CONNECTOR, END TO END, MULTI
Pioneer Surgical Technology, Inc.
10-RCEM
Not in Commercial Distribution

  • 00846468021580 ()
10-RCEM

  • Bone-screw internal spinal fixation system, non-sterile
ROD CONNECTOR, END TO END
Pioneer Surgical Technology, Inc.
10-RCE
Not in Commercial Distribution

  • 00846468021573 ()
10-RCE

  • Bone-screw internal spinal fixation system, non-sterile
RAPID REDUCER
Pioneer Surgical Technology, Inc.
10-RAPIDREDUCR
Not in Commercial Distribution

  • 00846468021566 ()


  • 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, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5003080-L
Not in Commercial Distribution

  • 00846468021511 ()
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

  • 00846468021504 ()
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

  • 00846468021498 ()
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

  • 00846468021481 ()
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

  • 00846468021474 ()
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

  • 00846468021467 ()
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

  • 00846468021450 ()
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

  • 00846468021443 ()
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

  • 00846468021436 ()
10-PJC5002070-L

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5002060-R
Not in Commercial Distribution

  • 00846468021429 ()
10-PJC5002060-R

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5002060-L
Not in Commercial Distribution

  • 00846468021412 ()
10-PJC5002060-L

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5002050-R
Not in Commercial Distribution

  • 00846468021405 ()
10-PJC5002050-R

  • Bone-screw internal spinal fixation system, non-sterile
PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5002050-L
Not in Commercial Distribution

  • 00846468021399 ()
10-PJC5002050-L

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE HOOK, SMALL
Pioneer Surgical Technology, Inc.
10-PH-S
Not in Commercial Distribution

  • 00846468021320 ()
10-PH-S

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE HOOK, MEDIUM
Pioneer Surgical Technology, Inc.
10-PH-M
Not in Commercial Distribution

  • 00846468021313 ()
10-PH-M

  • Bone-screw internal spinal fixation system, non-sterile
PEDICLE HOOK, LARGE
Pioneer Surgical Technology, Inc.
10-PH-L
Not in Commercial Distribution

  • 00846468021306 ()
10-PH-L

  • Bone-screw internal spinal fixation system, non-sterile
PALM STYLE HANDLE
Pioneer Surgical Technology, Inc.
10-PHANDLE
Not in Commercial Distribution

  • 00846468021290 ()


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

  • 00846468021283 ()


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

  • 00846468021276 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, SCREW, POLYAXIAL 7.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-775
Not in Commercial Distribution

  • 00846468021214 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, SCREW, POLYAXIAL 6.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-675
Not in Commercial Distribution

  • 00846468021207 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, SCREW, POLYAXIAL 5.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-575
Not in Commercial Distribution

  • 00846468021191 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, SCREW, POLYAXIAL 4.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-475
Not in Commercial Distribution

  • 00846468021184 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, SCREW, POLYAXIAL 4.00mm
Pioneer Surgical Technology, Inc.
10-PACADDY-400
Not in Commercial Distribution

  • 00846468021177 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-775
Not in Commercial Distribution

  • 00846468021160 ()


  • General internal orthopaedic fixation system implantation kit
CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-675
Not in Commercial Distribution

  • 00846468021153 ()


  • General internal orthopaedic fixation system implantation kit
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