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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Single-use cannulated drill bit Ø3.2
NOVASTEP
XDB01009D
In Commercial Distribution

  • 03700879508306 ()
XDB01009D

  • Cannulated surgical drill bit, single-use
Solid T25 large AO screwdriver tip
NOVASTEP
XSD06002
In Commercial Distribution

  • 03700879508283 ()
XSD06002

  • Surgical screwdriver, reusable
Solid T20 AO screwdriver tip
NOVASTEP
XSD05002
In Commercial Distribution

  • 03700879508276 ()
XSD05002

  • Surgical screwdriver, reusable
Concave reamer Ø18
NOVASTEP
XRE01011
In Commercial Distribution

  • 03700879508269 ()
XRE01011

  • Cannulated surgical drill bit, reusable
Convex reamer Ø18
NOVASTEP
XRE01010
In Commercial Distribution

  • 03700879508252 ()
XRE01010

  • Cannulated surgical drill bit, reusable
K-Wire Ø2.5 lg200 TR/RD
NOVASTEP
CKW01005
Not in Commercial Distribution

  • 03700879508245 ()
CKW01005

  • Orthopaedic intraoperative positioning pin, single-use
K-wire Ø1.6 lg180 TR/RD
NOVASTEP
CKW01004
In Commercial Distribution

  • 03700879508238 ()
CKW01004

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

  • 03700879508207 ()
PL030201

  • Orthopaedic fixation plate, non-bioabsorbable
Cleaning pin Ø1,6
NOVASTEP
XKW01003
In Commercial Distribution

  • 03700879508191 ()
XKW01003

  • Device sterilization/disinfection container, reusable
Trial plate holder
NOVASTEP
ACC1006P0004
Not in Commercial Distribution

  • 03700879508160 ()
ACC1006P0004

  • Device sterilization/disinfection container, reusable
Trial plate holder
NOVASTEP
ACC1006P0003
Not in Commercial Distribution

  • 03700879508153 ()
ACC1006P0003

  • 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 lg38
NOVASTEP
SP023538
In Commercial Distribution

  • 03700879508108 ()
SP023538

  • Orthopaedic bone screw (non-sliding)
Non-Locking screw Ø3.5 lg36
NOVASTEP
SP023536
In Commercial Distribution

  • 03700879508085 ()
SP023536

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

  • 03700879508061 ()
SP023534

  • Orthopaedic bone screw (non-sliding)
Non-Locking screw Ø3.5 lg32
NOVASTEP
SP023532
In Commercial Distribution

  • 03700879508047 ()
SP023532

  • 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 lg38
NOVASTEP
SP013538
In Commercial Distribution

  • 03700879508009 ()
SP013538

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø3.5 lg36
NOVASTEP
SP013536
In Commercial Distribution

  • 03700879507989 ()
SP013536

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

  • 03700879507965 ()
SP013534

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø3.5 lg32
NOVASTEP
SP013532
In Commercial Distribution

  • 03700879507941 ()
SP013532

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

  • 03700879507927 ()
ACC1005P0007

  • Device sterilization/disinfection container, reusable
Single Use Instrumentation
NOVASTEP
SUI02001
In Commercial Distribution

  • 03700879507880 ()
SUI02001

  • Cannulated surgical drill bit, single-use
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 7 holes trial plate
NOVASTEP
XTI04046
In Commercial Distribution

  • 03700879507859 ()
XTI04046

  • Surgical implant template, reusable
Utility 6 holes trial plate
NOVASTEP
XTI04040
In Commercial Distribution

  • 03700879507842 ()
XTI04040

  • Surgical implant template, reusable
Utility 5 holes trial plate
NOVASTEP
XTI04034
In Commercial Distribution

  • 03700879507835 ()
XTI04034

  • 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
Utility 2 holes trial plate
NOVASTEP
XTI04016
In Commercial Distribution

  • 03700879507804 ()
XTI04016

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

  • 03700879507798 ()
ACC1008P0004

  • Device sterilization/disinfection container, reusable
Lapidus plate step 1 trial Implant
NOVASTEP
XTI03011
In Commercial Distribution

  • 03700879507767 ()
XTI03011

  • Surgical implant template, reusable
Lapidus plate step 4 trial Implant
NOVASTEP
XTI03014
In Commercial Distribution

  • 03700879507750 ()
XTI03014

  • Surgical implant template, reusable
Lapidus plate step 3 trial Implant
NOVASTEP
XTI03013
In Commercial Distribution

  • 03700879507743 ()
XTI03013

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

  • 03700879507736 ()
XTI03012

  • Surgical implant template, reusable
Lapidus plate step 0 trial Implant
NOVASTEP
XTI03010
In Commercial Distribution

  • 03700879507729 ()
XTI03010

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

  • 03700879507712 ()
XHA01006

  • Surgical screwdriver, reusable
Adaptor 1/4 Hex-AO
NOVASTEP
XHA01005
In Commercial Distribution

  • 03700879507705 ()
XHA01005

  • Surgical screwdriver, reusable
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