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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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
Elevator
NOVASTEP
XMS01034
In Commercial Distribution

  • 03700879512556 ()
XMS01034

  • General internal orthopaedic fixation system implantation kit
Trial implant holder
NOVASTEP
ACC1015P0003
In Commercial Distribution

  • 03700879512532 ()
ACC1015P0003

  • Device sterilization/disinfection container, reusable
Lid
NOVASTEP
ACC1015P0002
In Commercial Distribution

  • 03700879512525 ()
ACC1015P0002

  • Device sterilization/disinfection container, reusable
Tray
NOVASTEP
ACC1015P0001
In Commercial Distribution

  • 03700879512518 ()
ACC1015P0001

  • Device sterilization/disinfection container, reusable
Spheric positioning pin single-use
NOVASTEP
XPP01005D
In Commercial Distribution

  • 03700879512501 ()
XPP01005D

  • Orthopaedic intraoperative positioning pin, single-use
K-wire holder
NOVASTEP
ACC1001P0020
In Commercial Distribution

  • 03700879512464 ()
ACC1001P0020

  • Device sterilization/disinfection container, reusable
countersink
NOVASTEP
XRE01022
In Commercial Distribution

  • 03700879512457 ()
XRE01022

  • Cannulated surgical drill bit, reusable
Depth gauge
NOVASTEP
XGA01011
In Commercial Distribution

  • 03700879512440 ()
XGA01011

  • Surgical implant template, reusable
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