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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 - 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

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 - 00846468001926

CADDY, LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-CADDY-LOC
Not in Commercial Distribution

10-CADDY-LOC

  • 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 - 00846468001902

CADDY, AUXILIARY SCREW
Pioneer Surgical Technology, Inc.
10-CADDY-AUX
Not in Commercial Distribution

10-CADDY-AUX

  • 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

Quantum Spinal Fixation System - 00846468001889

CORONAL BENDER, LEFT
Pioneer Surgical Technology, Inc.
10-BENDER-C-L
Not in Commercial Distribution

10-BENDER-C-L

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001872

BONE AWL
Pioneer Surgical Technology, Inc.
10-AWL-10-30
Not in Commercial Distribution


  • 10mm-30mm
10-AWL-10-30

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001865

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

10-ADJUSTER

  • General internal orthopaedic fixation system implantation kit

Streamline TL Spinal Fixation System - 00846468001827

ROD WRENCH, 3/16"
Xtant Medical Holdings, Inc.
10-RODWRENCH
Not in Commercial Distribution

10-RODWRENCH

  • Surgical implant/trial-implant/sizer holder, reusable
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