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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 - 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

Quantum Spinal Fixation System - 00846468002008

FIXED, ILIAC BOLT CADDY
Pioneer Surgical Technology, Inc.
10-FXBCADDY-875
Not in Commercial Distribution


  • 8.75mm
10-FXBCADDY-875

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001995

FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

10-FINALDRIVER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001971

ELEVATOR, LAMINA
Pioneer Surgical Technology, Inc.
10-ELEVATOR-L
Not in Commercial Distribution

10-ELEVATOR-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001964

CLAW ROD PUSHER
Pioneer Surgical Technology, Inc.
10-CLAWPUSHER
Not in Commercial Distribution

10-CLAWPUSHER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001957

CAP LOCKER, LONG
Pioneer Surgical Technology, Inc.
10-CAPLOCKER-L
Not in Commercial Distribution

10-CAPLOCKER-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001940

CAP INSERTER, LONG
Pioneer Surgical Technology, Inc.
10-CAPINSRTR-L
Not in Commercial Distribution

10-CAPINSRTR-L

  • General internal orthopaedic fixation system implantation kit
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