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 Class Implantable

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drill bit Ø1.5 Single use
NOVASTEP
XDB01019D
In Commercial Distribution

  • 03700879512037 ()
XDB01019D

  • Cannulated surgical drill bit, single-use
Cortical screw Ø2 lg22
NOVASTEP
SP032022
In Commercial Distribution

  • 03700879512020 ()
SP032022

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg20
NOVASTEP
SP032020
In Commercial Distribution

  • 03700879512013 ()
SP032020

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg18
NOVASTEP
SP032018
In Commercial Distribution

  • 03700879512006 ()
SP032018

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg16
NOVASTEP
SP032016
In Commercial Distribution

  • 03700879511993 ()
SP032016

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg14
NOVASTEP
SP032014
In Commercial Distribution

  • 03700879511986 ()
SP032014

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg12
NOVASTEP
SP032012
In Commercial Distribution

  • 03700879511979 ()
SP032012

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg22
NOVASTEP
SP012522
In Commercial Distribution

  • 03700879511962 ()
SP012522

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg20
NOVASTEP
SP012520
In Commercial Distribution

  • 03700879511955 ()
SP012520

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg18
NOVASTEP
SP012518
In Commercial Distribution

  • 03700879511948 ()
SP012518

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg16
NOVASTEP
SP012516
In Commercial Distribution

  • 03700879511931 ()
SP012516

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg14
NOVASTEP
SP012514
In Commercial Distribution

  • 03700879511924 ()
SP012514

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg12
NOVASTEP
SP012512
In Commercial Distribution

  • 03700879511917 ()
SP012512

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg10
NOVASTEP
SP012510
In Commercial Distribution

  • 03700879511900 ()
SP012510

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg8
NOVASTEP
SP012508
Not in Commercial Distribution

  • 03700879511894 ()
SP012508

  • Orthopaedic bone screw (non-sliding)
6mm Implant right
NOVASTEP
PL070106
In Commercial Distribution

  • 03700879511887 ()
PL070106

  • Orthopaedic fixation plate, non-bioabsorbable
4mm Implant right
NOVASTEP
PL070104
In Commercial Distribution

  • 03700879511870 ()
PL070104

  • Orthopaedic fixation plate, non-bioabsorbable
2mm Implant right
NOVASTEP
PL070102
In Commercial Distribution

  • 03700879511863 ()
PL070102

  • Orthopaedic fixation plate, non-bioabsorbable
6mm Implant left
NOVASTEP
PL070206
In Commercial Distribution

  • 03700879511856 ()
PL070206

  • Orthopaedic fixation plate, non-bioabsorbable
4mm Implant left
NOVASTEP
PL070204
In Commercial Distribution

  • 03700879511849 ()
PL070204

  • Orthopaedic fixation plate, non-bioabsorbable
2mm Implant left
NOVASTEP
PL070202
In Commercial Distribution

  • 03700879511832 ()
PL070202

  • Orthopaedic fixation plate, non-bioabsorbable
6mm trial implant Right
NOVASTEP
XTI06026
In Commercial Distribution

  • 03700879511825 ()
XTI06026

  • Surgical implant template, reusable
4mm trial implant Right
NOVASTEP
XTI06024
In Commercial Distribution

  • 03700879511818 ()
XTI06024

  • Surgical implant template, reusable
2mm trial implant Right
NOVASTEP
XTI06022
In Commercial Distribution

  • 03700879511801 ()
XTI06022

  • Surgical implant template, reusable
6mm trial implant Left
NOVASTEP
XTI06016
In Commercial Distribution

  • 03700879511795 ()
XTI06016

  • Surgical implant template, reusable
4mm trial implant Left
NOVASTEP
XTI06014
In Commercial Distribution

  • 03700879511788 ()
XTI06014

  • Surgical implant template, reusable
2mm trial implant Left
NOVASTEP
XTI06012
In Commercial Distribution

  • 03700879511771 ()
XTI06012

  • Surgical implant template, reusable
impactor
NOVASTEP
XMS01030
In Commercial Distribution

  • 03700879511757 ()
XMS01030

  • General internal orthopaedic fixation system implantation kit
screwdriver tip T7
NOVASTEP
XSD01003
In Commercial Distribution

  • 03700879511740 ()
XSD01003

  • Surgical screwdriver, reusable
drill bit Ø1.8
NOVASTEP
XDB01020
In Commercial Distribution

  • 03700879511733 ()
XDB01020

  • Cannulated surgical drill bit, reusable
drill bit Ø1.5
NOVASTEP
XDB01019
In Commercial Distribution

  • 03700879511726 ()
XDB01019

  • Cannulated surgical drill bit, reusable
Drill guide for screw Ø2,5
NOVASTEP
XDG01019
In Commercial Distribution

  • 03700879511719 ()
XDG01019

  • General internal orthopaedic fixation system implantation kit
Drill guide for screw Ø2
NOVASTEP
XDG01018
In Commercial Distribution

  • 03700879511702 ()
XDG01018

  • General internal orthopaedic fixation system implantation kit
targeting / compressing guide
NOVASTEP
XMS01026
In Commercial Distribution

  • 03700879511696 ()
XMS01026

  • General internal orthopaedic fixation system implantation kit
cannulated reamer
NOVASTEP
XRE01014
In Commercial Distribution

  • 03700879511689 ()
XRE01014

  • Cannulated surgical drill bit, reusable
Elevator
NOVASTEP
XMS01029
In Commercial Distribution

  • 03700879511672 ()
XMS01029

  • General internal orthopaedic fixation system implantation kit
Cutting guide
NOVASTEP
XMS01028
In Commercial Distribution

  • 03700879511665 ()
XMS01028

  • General internal orthopaedic fixation system implantation kit
K-wire Ø1,4 lg100 TR/RD CoCr
NOVASTEP
CKW02006
In Commercial Distribution

  • 03700879511658 ()
CKW02006

  • Orthopaedic intraoperative positioning pin, single-use
Ruler length 100
NOVASTEP
XGA01010
In Commercial Distribution

  • 03700879511610 ()
XGA01010

  • Surgical implant template, reusable
Tray
NOVASTEP
ACC1001P0019
In Commercial Distribution

  • 03700879511566 ()
ACC1001P0019

  • Device sterilization/disinfection container, reusable
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