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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 - 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 - 00846468002671

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

10-YOKEFORK

  • 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 - 00846468002633

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

10-XLINKWRENCH

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002626

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

10-XLINKGAGE

  • 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 - 00846468002565

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

10-VXLCADDY

  • 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 - 00846468002510

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

10-TAP-625-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 - 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 - 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 - 00846468002374

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

10-RR-HANDLE

  • 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 - 00846468002350

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

10-RODCADDY-RR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002343

CADDY, ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
10-RODCADDY-PR
Not in Commercial Distribution

10-RODCADDY-PR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002336

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

10-RODCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002329

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

10-ROCKER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002305

RAPID REDUCER
Pioneer Surgical Technology, Inc.
10-RAPIDREDUCR
Not in Commercial Distribution

10-RAPIDREDUCR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002282

CADDY, SCREW, POLYAXIAL 7.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-775
Not in Commercial Distribution

10-PACADDY-775

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002275

CADDY, SCREW, POLYAXIAL 6.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-675
Not in Commercial Distribution

10-PACADDY-675

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002268

CADDY, SCREW, POLYAXIAL 5.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-575
Not in Commercial Distribution

10-PACADDY-575

  • 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
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