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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 - 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
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