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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Tray
NOVASTEP
ACC1018P0001
In Commercial Distribution

  • 03700879513812 ()
ACC1018P0001

  • Device sterilization/disinfection container, reusable
Lapidus Long trial plate left
NOVASTEP
XTI03402
In Commercial Distribution

  • 03700879513720 ()
XTI03402

  • Surgical implant template, reusable
Lapidus Long trial plate right
NOVASTEP
XTI03401
In Commercial Distribution

  • 03700879513713 ()
XTI03401

  • Surgical implant template, reusable
Lapidus Short trial plate left
NOVASTEP
XTI03302
In Commercial Distribution

  • 03700879513706 ()
XTI03302

  • Surgical implant template, reusable
Lapidus Short trial plate right
NOVASTEP
XTI03301
In Commercial Distribution

  • 03700879513690 ()
XTI03301

  • Surgical implant template, reusable
Lapidus Long plate left
NOVASTEP
PL030402
In Commercial Distribution

  • 03700879513683 ()
PL030402

  • Orthopaedic fixation plate, non-bioabsorbable
Lapidus Long plate right
NOVASTEP
PL030401
In Commercial Distribution

  • 03700879513676 ()
PL030401

  • Orthopaedic fixation plate, non-bioabsorbable
Lapidus Short plate left
NOVASTEP
PL030302
In Commercial Distribution

  • 03700879513669 ()
PL030302

  • Orthopaedic fixation plate, non-bioabsorbable
Lapidus Short plate right
NOVASTEP
PL030301
In Commercial Distribution

  • 03700879513652 ()
PL030301

  • Orthopaedic fixation plate, non-bioabsorbable
K-Wire Ø1,2 lg100 TR/RD CoCr
NOVASTEP
CKW02007
In Commercial Distribution

  • 03700879513638 ()
CKW02007

  • Orthopaedic intraoperative positioning pin, single-use
K-Wire Ø1,2 lg100 TR/RD
NOVASTEP
CKW01014
In Commercial Distribution

  • 03700879513621 ()
CKW01014

  • Orthopaedic intraoperative positioning pin, single-use
cannulated drill bit Ø1.9 Single Use
NOVASTEP
XDB01025D
In Commercial Distribution

  • 03700879513614 ()
XDB01025D

  • Cannulated surgical drill bit, single-use
cannulated drill bit Ø1.9
NOVASTEP
XDB01025
In Commercial Distribution

  • 03700879513607 ()
XDB01025

  • Cannulated surgical drill bit, reusable
countersink Ø2.8 Single Use
NOVASTEP
XRE01024D
In Commercial Distribution

  • 03700879513591 ()
XRE01024D

  • Cannulated surgical drill bit, single-use
countersink Ø2.8
NOVASTEP
XRE01024
In Commercial Distribution

  • 03700879513584 ()
XRE01024

  • Cannulated surgical drill bit, reusable
Removal Exact-2 T8 AO screwdriver tip
NOVASTEP
XSD02007
In Commercial Distribution

  • 03700879513577 ()
XSD02007

  • Surgical screwdriver, reusable
Exact-2 T8 AO screwdriver tip
NOVASTEP
XSD02006
In Commercial Distribution

  • 03700879513560 ()
XSD02006

  • Surgical screwdriver, reusable
Trial plate holder
NOVASTEP
ACC1006P0006
Not in Commercial Distribution

  • 03700879513553 ()
ACC1006P0006

  • Device sterilization/disinfection container, reusable
Beveled compressive screw Ø2.7 lg28
NOVASTEP
SC090028
In Commercial Distribution

  • 03700879513485 ()
SC090028

  • Orthopaedic bone screw (non-sliding)
Beveled compressive screw Ø2.7 lg26
NOVASTEP
SC090026
In Commercial Distribution

  • 03700879513478 ()
SC090026

  • Orthopaedic bone screw (non-sliding)
Beveled compressive screw Ø2.7 lg20
NOVASTEP
SC090020
In Commercial Distribution

  • 03700879513447 ()
sc090020

  • Orthopaedic bone screw (non-sliding)
Beveled compressive implant Ø4 lg55
NOVASTEP
PS050155
In Commercial Distribution

  • 03700879513119 ()
PS050155

  • Orthopaedic bone screw (non-sliding)
Compressive forceps
NOVASTEP
XFP01012
In Commercial Distribution

  • 03700879512891 ()
XFP01012

  • General internal orthopaedic fixation system implantation kit
Threaded K-wire Ø2.5 - Opening Wedge distractor
NOVASTEP
CKW04001
In Commercial Distribution

  • 03700879512884 ()
CKW04001

  • Orthopaedic intraoperative positioning pin, single-use
Reduction wire Ø5
NOVASTEP
CKW03002
In Commercial Distribution

  • 03700879512877 ()
CKW03002

  • Orthopaedic intraoperative positioning pin, single-use
Straight impactor
NOVASTEP
XMS01036
In Commercial Distribution

  • 03700879512860 ()
XMS01036

  • General internal orthopaedic fixation system implantation kit
Single-use drill bit Ø2.5
NOVASTEP
XDB01022D
In Commercial Distribution

  • 03700879512839 ()
XDB01022D

  • Cannulated surgical drill bit, single-use
Single-use drill bit Ø2
NOVASTEP
XDB01021D
In Commercial Distribution

  • 03700879512822 ()
XDB01021D

  • Cannulated surgical drill bit, single-use
K-Wire Ø1 lg80 TR/RD
NOVASTEP
CKW01016
In Commercial Distribution

  • 03700879512815 ()
CKW01016

  • Orthopaedic intraoperative positioning pin, single-use
Threaded K-Wire Ø2,5 lg 200
NOVASTEP
CKW05002
Not in Commercial Distribution

  • 03700879512808 ()
CKW05002

  • Orthopaedic intraoperative positioning pin, single-use
Threaded K-Wire Ø1,6 lg 150
NOVASTEP
CKW05001
Not in Commercial Distribution

  • 03700879512792 ()
CKW05001

  • Orthopaedic intraoperative positioning pin, single-use
Foot support plate
NOVASTEP
ACC1002P0008
In Commercial Distribution

  • 03700879512785 ()
ACC1002P0008

  • Device sterilization/disinfection container, reusable
Oblong drill guide for screw Ø3
NOVASTEP
XDG01022
In Commercial Distribution

  • 03700879512778 ()
XDG01022

  • General internal orthopaedic fixation system implantation kit
Locking drill guide for screw Ø3 and Ø3.5
NOVASTEP
XDG01021
In Commercial Distribution

  • 03700879512761 ()
XDG01021

  • General internal orthopaedic fixation system implantation kit
Drill Bit Ø2.5
NOVASTEP
XDB01022
In Commercial Distribution

  • 03700879512754 ()
XDB01022

  • Cannulated surgical drill bit, reusable
Drill bit Ø2
NOVASTEP
XDB01021
In Commercial Distribution

  • 03700879512747 ()
XDB01021

  • Cannulated surgical drill bit, reusable
Distractors tray K-wires holder
NOVASTEP
ACC1016P0005
In Commercial Distribution

  • 03700879512730 ()
ACC1016P0005

  • Device sterilization/disinfection container, reusable
K-wires holder
NOVASTEP
ACC1016P0004
In Commercial Distribution

  • 03700879512723 ()
ACC1016P0004

  • Device sterilization/disinfection container, reusable
Lid
NOVASTEP
ACC1016P0003
In Commercial Distribution

  • 03700879512716 ()
ACC1016P0003

  • Device sterilization/disinfection container, reusable
Distractors tray
NOVASTEP
ACC1016P0002
In Commercial Distribution

  • 03700879512709 ()
ACC1016P0002

  • Device sterilization/disinfection container, reusable
Tray
NOVASTEP
ACC1016P0001
In Commercial Distribution

  • 03700879512693 ()
ACC1016P0001

  • Device sterilization/disinfection container, reusable
Opening wedge distractor
NOVASTEP
XFP01011
In Commercial Distribution

  • 03700879512662 ()
XFP01011

  • General internal orthopaedic fixation system implantation kit
Drill guide for screw Ø3.5
NOVASTEP
XDG01023
In Commercial Distribution

  • 03700879512655 ()
XDG01023

  • General internal orthopaedic fixation system implantation kit
Plates trial holder
NOVASTEP
ACC1006P0007
In Commercial Distribution

  • 03700879512648 ()
ACC1006P0007

  • Device sterilization/disinfection container, reusable
Fusion H Large trial plate
NOVASTEP
XTI04223
In Commercial Distribution

  • 03700879512617 ()
XTI04223

  • Surgical implant template, reusable
Fusion H Medium trial plate
NOVASTEP
XTI04220
In Commercial Distribution

  • 03700879512600 ()
XTI04220

  • Surgical implant template, reusable
Fusion H Small trial plate
NOVASTEP
XTI04217
In Commercial Distribution

  • 03700879512594 ()
XTI04217

  • Surgical implant template, reusable
Fusion Straight Long trial plate
NOVASTEP
XTI04123
In Commercial Distribution

  • 03700879512587 ()
XTI04123

  • Surgical implant template, reusable
Fusion Straight Medium trial plate
NOVASTEP
XTI04120
In Commercial Distribution

  • 03700879512570 ()
XTI04120

  • Surgical implant template, reusable
Fusion Straight Short trial plate
NOVASTEP
XTI04117
In Commercial Distribution

  • 03700879512563 ()
XTI04117

  • Surgical implant template, reusable
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