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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 - 00846468020934

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020927

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020903

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020897

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020880

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

Quantum® Spinal Fixation System - 00846468020873

CADDY, LOCKING CAP
Pioneer Surgical Technology, Inc.
10-LCAPCADDY
Not in Commercial Distribution

  • 00846468020873 ()


  • General internal orthopaedic fixation system implantation kit

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020866

LOCKING CAP
Pioneer Surgical Technology, Inc.
10-LCAP
Not in Commercial Distribution

  • 00846468020866 ()
10-LCAP

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

Quantum® Spinal Fixation System - 00846468020842

INSTRUMENT CASE, LUMBAR, SECONDARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-S
Not in Commercial Distribution

  • 00846468020842 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020835

INSTRUMENT CASE, LUMBAR, PRIMARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-P
Not in Commercial Distribution

  • 00846468020835 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020828

INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
10-INSTCASE
Not in Commercial Distribution

  • 00846468020828 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020811

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

  • 00846468020811 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020804

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

  • 00846468020804 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020798

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

  • 00846468020798 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020781

IMPLANT CASE, THORACOLUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE-TL
Not in Commercial Distribution

  • 00846468020781 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020774

IMPLANT CASE, LUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE
Not in Commercial Distribution

  • 00846468020774 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020767

HOOK PUSHER
Pioneer Surgical Technology, Inc.
10-HOOKPUSHER
Not in Commercial Distribution

  • 00846468020767 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020750

HOOK HOLDER, ANGLED
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER-A
Not in Commercial Distribution

  • 00846468020750 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020743

HOOK HOLDER
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER
Not in Commercial Distribution

  • 00846468020743 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020736

ROD GRIPPER, SMALL
Pioneer Surgical Technology, Inc.
10-GRIPPER-S
Not in Commercial Distribution

  • 00846468020736 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020712

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

  • 00846468020712 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020705

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

  • 00846468020705 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020699

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

  • 00846468020699 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020682

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

  • 00846468020682 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020651

CADDY, FIXED SCREW
Pioneer Surgical Technology, Inc.
10-FXCADDY-400
Not in Commercial Distribution

  • 00846468020651 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020644

FIXED, ILIAC BOLT CADDY
Pioneer Surgical Technology, Inc.
10-FXBCADDY-875
Not in Commercial Distribution

  • 00846468020644 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020637

FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

  • 00846468020637 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020620

ELEVATOR, PEDICLE
Pioneer Surgical Technology, Inc.
10-ELEVATOR-P
Not in Commercial Distribution

  • 00846468020620 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020613

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

  • 00846468020613 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020606

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

  • 00846468020606 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020590

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

  • 00846468020590 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020583

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

  • 00846468020583 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020576

ROD CUTTER CARTRIDGE
Pioneer Surgical Technology, Inc.
10-CUTCART-635
Not in Commercial Distribution

  • 00846468020576 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020569

ROD CUTTER CARTRIDGE
Pioneer Surgical Technology, Inc.
10-CUTCART-60
Not in Commercial Distribution

  • 00846468020569 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020552

ROD CUTTER CARTRIDGE
Pioneer Surgical Technology, Inc.
10-CUTCART-55
Not in Commercial Distribution

  • 00846468020552 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020545

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

  • 00846468020545 ()
10-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020538

CLAW ROD PUSHER
Pioneer Surgical Technology, Inc.
10-CLAWPUSHER
Not in Commercial Distribution

  • 00846468020538 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020521

PEDICLE FINDER, CURVED, SMALL, SQUARE TIP
Pioneer Surgical Technology, Inc.
10-CFINDER-SM-S
Not in Commercial Distribution

  • 00846468020521 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020514

PEDICLE FINDER, CURVED
Pioneer Surgical Technology, Inc.
10-CFINDER
Not in Commercial Distribution

  • 00846468020514 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020507

BALLTIP, CURVED
Pioneer Surgical Technology, Inc.
10-CBALLTIP
Not in Commercial Distribution

  • 00846468020507 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020491

CAP LOCKER, LONG
Pioneer Surgical Technology, Inc.
10-CAPLOCKER-L
Not in Commercial Distribution

  • 00846468020491 ()


  • General internal orthopaedic fixation system implantation kit
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