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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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Threshold Pedicular Fixation System - M7405530021

Rod Caliper
SPINEOLOGY INC.
55-06-01
In Commercial Distribution

  • M7405530021 ()
553-0021

  • Surgical screwdriver, reusable

Threshold Pedicular Fixation System - M7405530017

Rod Pusher
SPINEOLOGY INC.
10-62-13
In Commercial Distribution

  • M7405530017 ()
553-0017

  • Surgical screwdriver, reusable

Threshold Pedicular Fixation System - M7405530009

Rod Template (150mm)
SPINEOLOGY INC.
10-62-08
In Commercial Distribution

  • M7405530009 ()
553-0009

  • Surgical screwdriver, reusable

Threshold Pedicular Fixation System - M7405530001

Screwdriver (both must have same Catalog #)
SPINEOLOGY INC.
55-03-10
In Commercial Distribution

  • M7405530001 ()
553-0001

  • Surgical screwdriver, reusable

Elite Expandable Interbody Fusion System - M7405409501

Driver, T-15 Hex, Small AO
SPINEOLOGY INC.
54-95-01
In Commercial Distribution

  • M7405409501 ()
540-9501

  • Surgical screwdriver, reusable

Threshold Pedicular Fixation System - M7405300023

Screwdriver
SPINEOLOGY INC.
53-09-10
In Commercial Distribution

  • M7405300023 ()
530-0023

  • Surgical screwdriver, reusable

Palisade Pedicular Fixation System - M7406710016

Screwdriver
SPINEOLOGY INC.
67-02-01
In Commercial Distribution

  • M7406710016 ()
671-0016

  • Surgical screwdriver, reusable

Rampart One Lumbar Interbody Fusion System - M7404901812

Variable Angle Driver
SPINEOLOGY INC.
49-01-67
In Commercial Distribution

  • M7404901812 ()
490-1812

  • Surgical screwdriver, reusable

Rampart One Lumbar Interbody Fusion System - M7404901809

Straight Driver
SPINEOLOGY INC.
49-01-24
In Commercial Distribution

  • M7404901809 ()
490-1809

  • Surgical screwdriver, reusable

Palisade Pedicular Fixation System - M7406710078

Extra Short Palisade Driver
SPINEOLOGY INC.
67-25-01
In Commercial Distribution

  • M7406710078 ()
671-0078

  • Surgical screwdriver, reusable
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