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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 - 00846468089009

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-14-FXL
Not in Commercial Distribution


  • 14mm
10-14-FXL

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

Quantum Spinal Fixation System - 00846468088989

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-12-FXL
Not in Commercial Distribution


  • 12mm
10-12-FXL

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

Quantum Spinal Fixation System - 00846468001988

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

10-ELEVATOR-P

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468000165

QSRS, PEDICLE SCREW INSRTR, HUSDON DRIVE
Pioneer Surgical Technology, Inc.
724-980
Not in Commercial Distribution

  • 00846468000165 ()
724-980

  • Orthopaedic prosthesis implantation positioning instrument, reusable

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 - 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 - 00846468002657

X-LINK BENDER, PERPENDICULAR
Pioneer Surgical Technology, Inc.
10-XLNKBNDRPER
Not in Commercial Distribution

10-XLNKBNDRPER

  • 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
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