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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 - 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 - 00846468002428

STABILIZING TUBE
Pioneer Surgical Technology, Inc.
10-STABTUBE
Not in Commercial Distribution

10-STABTUBE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002411

SCREW INSERTER
Pioneer Surgical Technology, Inc.
10-SCRWINSERT-S
Not in Commercial Distribution

10-SCRWINSERT-S

  • 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
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