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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 - 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 - 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 - 00846468002541

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

10-TAP-725-E

  • General internal orthopaedic fixation system implantation kit
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