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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TAP, 4.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-425-1
Not in Commercial Distribution

  • 00846468022006 ()


  • General internal orthopaedic fixation system implantation kit
TAP, 4.25mm
Pioneer Surgical Technology, Inc.
10-TAP-425
Not in Commercial Distribution

  • 00846468021993 ()


  • General internal orthopaedic fixation system implantation kit
SWIZZLE STICK (Head Adjuster)
Pioneer Surgical Technology, Inc.
10-SWIZZLESTIK
Not in Commercial Distribution

  • 00846468021979 ()


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

  • 00846468021955 ()


  • General internal orthopaedic fixation system implantation kit
PEDICLE FINDER, STRAIGHT, SMALL, SQUARE TIP
Pioneer Surgical Technology, Inc.
10-SFINDER-SM-S
Not in Commercial Distribution

  • 00846468021900 ()


  • General internal orthopaedic fixation system implantation kit
PEDICLE FINDER, STRAIGHT, LENKE, LONG
Pioneer Surgical Technology, Inc.
10-SFINDER-LE-L
Not in Commercial Distribution

  • 00846468021894 ()


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

  • 00846468021818 ()


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

  • 00846468021795 ()


  • 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
ROD WRENCH, 3/16"
Pioneer Surgical Technology, Inc.
10-RODWRENCH
Not in Commercial Distribution

  • 00846468021757 ()


  • 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
CADDY, ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
10-RODCADDY-RR
Not in Commercial Distribution

  • 00846468021696 ()


  • 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
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, MEDIUM
Pioneer Surgical Technology, Inc.
10-PH-M
Not in Commercial Distribution

  • 00846468021313 ()
10-PH-M

  • Bone-screw internal spinal fixation system, non-sterile
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
PEDICLE MARKER, 90mm
Pioneer Surgical Technology, Inc.
10-MARKER-90
Not in Commercial Distribution

  • 00846468021108 ()


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

  • 00846468021092 ()


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

  • 00846468021085 ()


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

  • 00846468021078 ()


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

  • 00846468021009 ()


  • General internal orthopaedic fixation system implantation kit
LAMINAR HOOK, LUMBAR, SMALL
Pioneer Surgical Technology, Inc.
10-LLH-S
Not in Commercial Distribution

  • 00846468020958 ()
10-LLH-S

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

  • 00846468020934 ()
10-LLH-L

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

  • 00846468020927 ()
10-LLHE-S

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

  • 00846468020903 ()
10-LLHE-L

  • Bone-screw internal spinal fixation system, non-sterile
LAMINAR HOOK, OFFSET RIGHT
Pioneer Surgical Technology, Inc.
10-LHO-R
Not in Commercial Distribution

  • 00846468020897 ()
10-LHO-R

  • Bone-screw internal spinal fixation system, non-sterile
LAMINAR HOOK, OFFSET LEFT
Pioneer Surgical Technology, Inc.
10-LHO-L
Not in Commercial Distribution

  • 00846468020880 ()
10-LHO-L

  • Bone-screw internal spinal fixation system, non-sterile
CADDY, LOCKING CAP
Pioneer Surgical Technology, Inc.
10-LCAPCADDY
Not in Commercial Distribution

  • 00846468020873 ()


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

  • 00846468020866 ()
10-LCAP

  • Bone-screw internal spinal fixation system, non-sterile
INSTRUMENT CASE, LUMBAR, SECONDARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-S
Not in Commercial Distribution

  • 00846468020842 ()


  • General internal orthopaedic fixation system implantation kit
INSTRUMENT CASE, LUMBAR, PRIMARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-P
Not in Commercial Distribution

  • 00846468020835 ()


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

  • 00846468020828 ()


  • General internal orthopaedic fixation system implantation kit
IN-SITU ROD BENDER, RIGHT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-R
Not in Commercial Distribution

  • 00846468020811 ()


  • General internal orthopaedic fixation system implantation kit
IN-SITU ROD BENDER, LEFT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-L
Not in Commercial Distribution

  • 00846468020804 ()


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

  • 00846468020798 ()


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

  • 00846468020781 ()


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

  • 00846468020774 ()


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

  • 00846468020767 ()


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

  • 00846468020750 ()


  • General internal orthopaedic fixation system implantation kit
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