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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 - 00846468001964

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

10-CLAWPUSHER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001957

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

10-CAPLOCKER-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001940

CAP INSERTER, LONG
Pioneer Surgical Technology, Inc.
10-CAPINSRTR-L
Not in Commercial Distribution

10-CAPINSRTR-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001933

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

10-CAPINSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001926

CADDY, LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-CADDY-LOC
Not in Commercial Distribution

10-CADDY-LOC

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001919

CADDY, HOOK
Pioneer Surgical Technology, Inc.
10-CADDY-HOOKS
Not in Commercial Distribution

10-CADDY-HOOKS

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001902

CADDY, AUXILIARY SCREW
Pioneer Surgical Technology, Inc.
10-CADDY-AUX
Not in Commercial Distribution

10-CADDY-AUX

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001896

CORONAL BENDER, RIGHT
Pioneer Surgical Technology, Inc.
10-BENDER-C-R
Not in Commercial Distribution

10-BENDER-C-R

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001889

CORONAL BENDER, LEFT
Pioneer Surgical Technology, Inc.
10-BENDER-C-L
Not in Commercial Distribution

10-BENDER-C-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001872

BONE AWL
Pioneer Surgical Technology, Inc.
10-AWL-10-30
Not in Commercial Distribution


  • 10mm-30mm
10-AWL-10-30

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001865

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

10-ADJUSTER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002664

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

10-XLNKHOLDER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002640

X-LINK BENDER, PARALLEL
Pioneer Surgical Technology, Inc.
10-XLNKBNDRPAR
Not in Commercial Distribution

10-XLNKBNDRPAR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002619

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

10-XLINKDRIVER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002602

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

10-XLCASE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002596

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

10-VXLG-6080

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002589

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

10-VXLG-4060

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002572

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

10-VXLG-3040

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002558

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

10-TAPSLEEVE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002534

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

10-TAP-725-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002527

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

10-TAP-725

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002503

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

10-TAP-625-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002497

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

10-TAP-625

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002480

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

10-TAP-525-E

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002473

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

10-TAP-525-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002466

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

10-TAP-525

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002459

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

10-TAP-425-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002435

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

10-TAP-350

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002428

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

10-STABTUBE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002404

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

10-SCRWINSERT

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002381

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

10-SCREWGAGE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002367

ROD FORCEPS, 25°, Ø 5.5mm
Pioneer Surgical Technology, Inc.
10-RODFORCEP-25
Not in Commercial Distribution

10-RODFORCEP-25

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002244

CADDY, SCREW, POLYAXIAL 4.00mm
Pioneer Surgical Technology, Inc.
10-PACADDY-400
Not in Commercial Distribution

10-PACADDY-400

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002220

CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-675
Not in Commercial Distribution


  • 6.75mm
10-PABCADDY-675

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002206

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

10-MANIPULATOR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002183

LOCKING TUBE
Pioneer Surgical Technology, Inc.
10-LOCKINGTUBE
Not in Commercial Distribution

10-LOCKINGTUBE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002176

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

10-LCAPCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002169

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

  • 00846468002169 ()
10-INSTCASE-TL

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002145

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

10-INSTCASE-P

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002121

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

10-INSITUBEND-R

  • General internal orthopaedic fixation system implantation kit
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