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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 - 00846468002121

IN-SITU ROD BENDER, RIGHT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-R
Not in Commercial Distribution

10-INSITUBEND-R

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002114

IN-SITU ROD BENDER, LEFT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-L
Not in Commercial Distribution

10-INSITUBEND-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002107

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

10-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002091

IMPLANT CASE, THORACOLUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE-TL
Not in Commercial Distribution

10-IMPCASE-TL

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002084

IMPLANT CASE, LUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE
Not in Commercial Distribution

10-IMPCASE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002077

HOOK PUSHER
Pioneer Surgical Technology, Inc.
10-HOOKPUSHER
Not in Commercial Distribution

10-HOOKPUSHER

  • 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 - 00846468001933

INITIAL INSERTER
Pioneer Surgical Technology, Inc.
10-CAPINSERTER
Not in Commercial Distribution

10-CAPINSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001919

CADDY, HOOK
Pioneer Surgical Technology, Inc.
10-CADDY-HOOKS
Not in Commercial Distribution

10-CADDY-HOOKS

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001896

CORONAL BENDER, RIGHT
Pioneer Surgical Technology, Inc.
10-BENDER-C-R
Not in Commercial Distribution

10-BENDER-C-R

  • General internal orthopaedic fixation system implantation kit
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