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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K-Wire Ø2.5 lg200 TR/RD
NOVASTEP
CKW01005
Not in Commercial Distribution

  • 03700879508245 ()
CKW01005

  • Orthopaedic intraoperative positioning pin, single-use
Lapidus Plate Step 1
NOVASTEP
PL030201
In Commercial Distribution

  • 03700879508207 ()
PL030201

  • Orthopaedic fixation plate, non-bioabsorbable
Trial plate holder
NOVASTEP
ACC1006P0004
Not in Commercial Distribution

  • 03700879508160 ()
ACC1006P0004

  • Device sterilization/disinfection container, reusable
MTP plate trial holder
NOVASTEP
ACC1006P0002
Not in Commercial Distribution

  • 03700879508146 ()
ACC1006P0002

  • Device sterilization/disinfection container, reusable
Non-Locking screw Ø3.5 lg40
NOVASTEP
SP023540
In Commercial Distribution

  • 03700879508122 ()
SP023540

  • Orthopaedic bone screw (non-sliding)
Non-Locking screw Ø3.5 lg34
NOVASTEP
SP023534
In Commercial Distribution

  • 03700879508061 ()
SP023534

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø3.5 lg40
NOVASTEP
SP013540
In Commercial Distribution

  • 03700879508023 ()
SP013540

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø3.5 lg34
NOVASTEP
SP013534
In Commercial Distribution

  • 03700879507965 ()
SP013534

  • Orthopaedic bone screw (non-sliding)
Module
NOVASTEP
ACC1005P0007
In Commercial Distribution

  • 03700879507927 ()
ACC1005P0007

  • Device sterilization/disinfection container, reusable
Ø4 Single Use Instrumentation
NOVASTEP
SUI01002
In Commercial Distribution

  • 03700879507873 ()
SUI01002

  • Cannulated surgical drill bit, single-use
Single Use Instrumentation
NOVASTEP
SUI01001
In Commercial Distribution

  • 03700879507866 ()
SUI01001

  • Cannulated surgical drill bit, single-use
Utility 6 holes trial plate
NOVASTEP
XTI04040
In Commercial Distribution

  • 03700879507842 ()
XTI04040

  • Surgical implant template, reusable
Utility 4 holes trial plate
NOVASTEP
XTI04028
In Commercial Distribution

  • 03700879507828 ()
XTI04028

  • Surgical implant template, reusable
Utility 3 holes trial plate
NOVASTEP
XTI04022
In Commercial Distribution

  • 03700879507811 ()
XTI04022

  • Surgical implant template, reusable
K-wire holder
NOVASTEP
ACC1008P0004
In Commercial Distribution

  • 03700879507798 ()
ACC1008P0004

  • Device sterilization/disinfection container, reusable
Lapidus plate step 4 trial Implant
NOVASTEP
XTI03014
In Commercial Distribution

  • 03700879507750 ()
XTI03014

  • Surgical implant template, reusable
Lapidus plate step 2 trial Implant
NOVASTEP
XTI03012
In Commercial Distribution

  • 03700879507736 ()
XTI03012

  • Surgical implant template, reusable
Adaptor AO-1/4 Hex
NOVASTEP
XHA01006
In Commercial Distribution

  • 03700879507712 ()
XHA01006

  • Surgical screwdriver, reusable
Large AO straight handle
NOVASTEP
XHA01003
In Commercial Distribution

  • 03700879507682 ()
XHA01003

  • General internal orthopaedic fixation system implantation kit
Tissue protector
NOVASTEP
XDG01016
In Commercial Distribution

  • 03700879507606 ()
XDG01016

  • General internal orthopaedic fixation system implantation kit
Silicon mat
NOVASTEP
ACC1008P0003
In Commercial Distribution

  • 03700879507576 ()
ACC1008P0003

  • Device sterilization/disinfection container, reusable
Lid
NOVASTEP
ACC1008P0002
In Commercial Distribution

  • 03700879507569 ()
ACC1008P0002

  • Device sterilization/disinfection container, reusable
Tray
NOVASTEP
ACC1008P0001
In Commercial Distribution

  • 03700879507552 ()
ACC1008P0001

  • Device sterilization/disinfection container, reusable
Ø4,8 canulated drill bit
NOVASTEP
XDB01010
In Commercial Distribution

  • 03700879507545 ()
XDB01010

  • Cannulated surgical drill bit, reusable
Countersink Ø6
NOVASTEP
XRE01009
In Commercial Distribution

  • 03700879507521 ()
XRE01009

  • Cannulated surgical drill bit, reusable
Countersink Ø4.9
NOVASTEP
XRE01008
In Commercial Distribution

  • 03700879507514 ()
XRE01008

  • Cannulated surgical drill bit, reusable
Nexis T20 canulated screwdriver tip
NOVASTEP
XSD06001
Not in Commercial Distribution

  • 03700879507507 ()
XSD06001

  • General internal orthopaedic fixation system implantation kit
Screw Ø7 length 90 short thread
NOVASTEP
SC070090
In Commercial Distribution

  • 03700879507019 ()
SC070090

  • Orthopaedic bone screw (non-sliding)
Screw Ø7 length 85 short thread
NOVASTEP
SC070085
In Commercial Distribution

  • 03700879506999 ()
SC070085

  • Orthopaedic bone screw (non-sliding)
Screw Ø7 length 80 short thread
NOVASTEP
SC070080
In Commercial Distribution

  • 03700879506975 ()
SC070080

  • Orthopaedic bone screw (non-sliding)
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