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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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Quantum® Spinal Fixation System - 00846468022358

10-YOKEFORK
Pioneer Surgical Technology, Inc.
10-YOKEFORK
Not in Commercial Distribution

  • 00846468022358 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022341

10-XLNKHOLDER
Pioneer Surgical Technology, Inc.
10-XLNKHOLDER
Not in Commercial Distribution

  • 00846468022341 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022334

10-XLNKBNDRPER
Pioneer Surgical Technology, Inc.
10-XLNKBNDRPER
Not in Commercial Distribution

  • 00846468022334 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022327

10-XLNKBNDRPAR
Pioneer Surgical Technology, Inc.
10-XLNKBNDRPAR
Not in Commercial Distribution

  • 00846468022327 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022310

10-XLINKWRENCH
Pioneer Surgical Technology, Inc.
10-XLINKWRENCH
Not in Commercial Distribution

  • 00846468022310 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022303

X-LINK® GAGE
Pioneer Surgical Technology, Inc.
10-XLINKGAGE
Not in Commercial Distribution

  • 00846468022303 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022297

DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022280

CASE, X-LINK™
Pioneer Surgical Technology, Inc.
10-XLCASE
Not in Commercial Distribution

  • 00846468022280 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022259

GAGE, X-LINK®, VARIABLE, 60mm-80mm
Pioneer Surgical Technology, Inc.
10-VXLG-6080
Not in Commercial Distribution

  • 00846468022259 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022242

GAGE, X-LINK®, VARIABLE, 40mm-60mm
Pioneer Surgical Technology, Inc.
10-VXLG-4060
Not in Commercial Distribution

  • 00846468022242 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022235

GAGE, X-LINK®, VARIABLE, 30mm-40mm
Pioneer Surgical Technology, Inc.
10-VXLG-3040
Not in Commercial Distribution

  • 00846468022235 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022228

CADDY, X-LINK™, VARIABLE
Pioneer Surgical Technology, Inc.
10-VXLCADDY
Not in Commercial Distribution

  • 00846468022228 ()


  • General internal orthopaedic fixation system implantation kit

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022211

THORACIC LAMINAR HOOK, SMALL
Pioneer Surgical Technology, Inc.
10-TLH-S
Not in Commercial Distribution

  • 00846468022211 ()
10-TLH-S

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022204

THORACIC LAMINAR HOOK, LARGE
Pioneer Surgical Technology, Inc.
10-TLH-L
Not in Commercial Distribution

  • 00846468022204 ()
10-TLH-L

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022198

THORACIC LAMINAR HOOK, ANGLED, RIGHT
Pioneer Surgical Technology, Inc.
10-TLHA-R
Not in Commercial Distribution

  • 00846468022198 ()
10-TLHA-R

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

Quantum® Spinal Fixation System - 00846468022181

DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022174

THORACIC LAMINAR HOOK, ANGLED, LEFT
Pioneer Surgical Technology, Inc.
10-TLHA-L
Not in Commercial Distribution

  • 00846468022174 ()
10-TLHA-L

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

Quantum® Spinal Fixation System - 00846468022150

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

  • 00846468022150 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022143

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-600
Not in Commercial Distribution

  • 00846468022143 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022136

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-400
Not in Commercial Distribution

  • 00846468022136 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022129

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-250
Not in Commercial Distribution

  • 00846468022129 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022112

TAP SLEEVE
Pioneer Surgical Technology, Inc.
10-TAPSLEEVE
Not in Commercial Distribution

  • 00846468022112 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022105

TAP, 7.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-725-E
Not in Commercial Distribution

  • 00846468022105 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022099

TAP, 7.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-725-1
Not in Commercial Distribution

  • 00846468022099 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022082

TAP, 7.25mm
Pioneer Surgical Technology, Inc.
10-TAP-725
Not in Commercial Distribution

  • 00846468022082 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022075

TAP, 6.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-625-E
Not in Commercial Distribution

  • 00846468022075 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022068

TAP, 6.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-625-1
Not in Commercial Distribution

  • 00846468022068 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022051

TAP, 6.25mm
Pioneer Surgical Technology, Inc.
10-TAP-625
Not in Commercial Distribution

  • 00846468022051 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022044

TAP, 5.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-525-E
Not in Commercial Distribution

  • 00846468022044 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022037

TAP, 5.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-525-1
Not in Commercial Distribution

  • 00846468022037 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022020

TAP, 5.25mm
Pioneer Surgical Technology, Inc.
10-TAP-525
Not in Commercial Distribution

  • 00846468022020 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022006

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

Quantum® Spinal Fixation System - 00846468021993

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

  • 00846468021993 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021986

TAP, 3.5mm
Pioneer Surgical Technology, Inc.
10-TAP-350
Not in Commercial Distribution

  • 00846468021986 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021979

SWIZZLE STICK (Head Adjuster)
Pioneer Surgical Technology, Inc.
10-SWIZZLESTIK
Not in Commercial Distribution

  • 00846468021979 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021955

STABILIZING TUBE
Pioneer Surgical Technology, Inc.
10-STABTUBE
Not in Commercial Distribution

  • 00846468021955 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021917

FIXED STRAIGHT HANDLE, 1/4" SDQC
Pioneer Surgical Technology, Inc.
10-SHANDLE
Not in Commercial Distribution

  • 00846468021917 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021900

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

Quantum® Spinal Fixation System - 00846468021894

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

Quantum® Spinal Fixation System - 00846468021887

PEDICLE FINDER, STRAIGHT, DUCKBILL, LONG
Pioneer Surgical Technology, Inc.
10-SFINDER-DB-L
Not in Commercial Distribution

  • 00846468021887 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021870

PEDICLE FINDER, STRAIGHT
Pioneer Surgical Technology, Inc.
10-SFINDER
Not in Commercial Distribution

  • 00846468021870 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021863

SCREW INSERTER
Pioneer Surgical Technology, Inc.
10-SCRWINSERT-S
Not in Commercial Distribution

  • 00846468021863 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021856

SCREW INSERTER
Pioneer Surgical Technology, Inc.
10-SCRWINSERT
Not in Commercial Distribution

  • 00846468021856 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021849

SCREW GAGE
Pioneer Surgical Technology, Inc.
10-SCREWGAGE
Not in Commercial Distribution

  • 00846468021849 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021818

BALLTIP, STRAIGHT
Pioneer Surgical Technology, Inc.
10-SBALLTIP-R
Not in Commercial Distribution

  • 00846468021818 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021801

BALLTIP, STRAIGHT
Pioneer Surgical Technology, Inc.
10-SBALLTIP
Not in Commercial Distribution

  • 00846468021801 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021795

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

  • 00846468021795 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021788

RATCHETING STRAIGHT HANDLE, 1/4" SDQC
Pioneer Surgical Technology, Inc.
10-RSHANDLE
Not in Commercial Distribution

  • 00846468021788 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021771

COUNTER TORQUE WRENCH
Pioneer Surgical Technology, Inc.
10-RR-HANDLE
Not in Commercial Distribution

  • 00846468021771 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021764

RATCHETING PALM HANDLE, 1/4" SDQC
Pioneer Surgical Technology, Inc.
10-RPHANDLE
Not in Commercial Distribution

  • 00846468021764 ()


  • General internal orthopaedic fixation system implantation kit
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