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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 - 00846468002244

CADDY, SCREW, POLYAXIAL 4.00mm
Pioneer Surgical Technology, Inc.
10-PACADDY-400
Not in Commercial Distribution

10-PACADDY-400

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002220

CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-675
Not in Commercial Distribution


  • 6.75mm
10-PABCADDY-675

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002206

ROD REDUCER
Pioneer Surgical Technology, Inc.
10-MANIPULATOR
Not in Commercial Distribution

10-MANIPULATOR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002183

LOCKING TUBE
Pioneer Surgical Technology, Inc.
10-LOCKINGTUBE
Not in Commercial Distribution

10-LOCKINGTUBE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002060

HOOK HOLDER, ANGLED
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER-A
Not in Commercial Distribution

10-HOOKHOLDER-A

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002053

HOOK HOLDER
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER
Not in Commercial Distribution

10-HOOKHOLDER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002046

GOUGE
Pioneer Surgical Technology, Inc.
10-GOUGE
Not in Commercial Distribution

10-GOUGE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002039

GAGE, FIXED X-LINK
Pioneer Surgical Technology, Inc.
10-FXLGAGE
Not in Commercial Distribution

10-FXLGAGE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002022

CADDY, X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-FXLCADDY
Not in Commercial Distribution

10-FXLCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002015

CADDY, FIXED SCREW
Pioneer Surgical Technology, Inc.
10-FXCADDY-400
Not in Commercial Distribution


  • 4.00mm
10-FXCADDY-400

  • General internal orthopaedic fixation system implantation kit
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