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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Beveled compressive implant Ø4 lg18
NOVASTEP
PS050118
In Commercial Distribution

  • 03700879512945 ()
PS050118

  • Orthopaedic bone screw (non-sliding)
Non-locking drill guide for screw Ø3 and Ø3.5
NOVASTEP
XDG01020
In Commercial Distribution

  • 03700879512907 ()
XDG01020

  • General internal orthopaedic fixation system implantation kit
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
Foot support plate
NOVASTEP
ACC1002P0008
In Commercial Distribution

  • 03700879512785 ()
ACC1002P0008

  • Device sterilization/disinfection container, reusable
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