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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
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