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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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
Concave reamer Ø22
NOVASTEP
XRE01021
In Commercial Distribution

  • 03700879512433 ()
XRE01021

  • Cannulated surgical drill bit, reusable
Concave reamer Ø20
NOVASTEP
XRE01020
In Commercial Distribution

  • 03700879512426 ()
XRE01020

  • Cannulated surgical drill bit, reusable
Concave reamer Ø18
NOVASTEP
XRE01019
In Commercial Distribution

  • 03700879512419 ()
XRE01019

  • Cannulated surgical drill bit, reusable
Convex reamer Ø22
NOVASTEP
XRE01018
In Commercial Distribution

  • 03700879512402 ()
XRE01018

  • Cannulated surgical drill bit, reusable
Convex reamer Ø20
NOVASTEP
XRE01017
In Commercial Distribution

  • 03700879512396 ()
XRE01017

  • Cannulated surgical drill bit, reusable
Convex reamer Ø18
NOVASTEP
XRE01016
In Commercial Distribution

  • 03700879512389 ()
XRE01016

  • Cannulated surgical drill bit, reusable
countersink Single use
NOVASTEP
XRE01022D
In Commercial Distribution

  • 03700879512341 ()
XRE01022D

  • Cannulated surgical drill bit, single-use
Centrolock temporary fixation pin
NOVASTEP
XPP01005
Not in Commercial Distribution

  • 03700879512334 ()
XPP01005

  • General internal orthopaedic fixation system implantation kit
Cortical screw Ø2 lg24
NOVASTEP
SP032024
In Commercial Distribution

  • 03700879512327 ()
SP032024

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg26
NOVASTEP
SP012526
In Commercial Distribution

  • 03700879512310 ()
SP012526

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg24
NOVASTEP
SP012524
In Commercial Distribution

  • 03700879512303 ()
SP012524

  • Orthopaedic bone screw (non-sliding)
Fusion H Long plate
NOVASTEP
PL040223
In Commercial Distribution

  • 03700879512297 ()
PL040223

  • Orthopaedic fixation plate, non-bioabsorbable
Fusion H Medium plate
NOVASTEP
PL040220
In Commercial Distribution

  • 03700879512280 ()
PL040220

  • Orthopaedic fixation plate, non-bioabsorbable
Fusion H Short plate
NOVASTEP
PL040217
In Commercial Distribution

  • 03700879512273 ()
PL040217

  • Orthopaedic fixation plate, non-bioabsorbable
Fusion Straight Long plate
NOVASTEP
PL040123
In Commercial Distribution

  • 03700879512266 ()
PL040123

  • Orthopaedic fixation plate, non-bioabsorbable
Fusion Straight Medium plate
NOVASTEP
PL040120
In Commercial Distribution

  • 03700879512259 ()
PL040120

  • Orthopaedic fixation plate, non-bioabsorbable
Fusion Straight Short plate
NOVASTEP
PL040117
In Commercial Distribution

  • 03700879512242 ()
PL040117

  • Orthopaedic fixation plate, non-bioabsorbable
K-Wire Ø2 lg150 TR/RD
NOVASTEP
CKW01013
In Commercial Distribution

  • 03700879512235 ()
CKW01013

  • Orthopaedic intraoperative positioning pin, single-use
K-Wire Ø2 lg100 TR/RD
NOVASTEP
CKW01012
In Commercial Distribution

  • 03700879512228 ()
CKW01012

  • Orthopaedic intraoperative positioning pin, single-use
T8 screwdriver non cannulated
NOVASTEP
XSD02005
In Commercial Distribution

  • 03700879512211 ()
XSD02005

  • Surgical screwdriver, reusable
Staple Tray - Hindfoot
NOVASTEP
139-00-0002
In Commercial Distribution

  • 03700879512204 ()
139-00-0002

  • Device sterilization/disinfection container, reusable
Tray lid
NOVASTEP
139-00-0001
In Commercial Distribution

  • 03700879512198 ()
139-00-0001

  • Device sterilization/disinfection container, reusable
Large Staple Impactor
NOVASTEP
139-00-0021
In Commercial Distribution

  • 03700879512181 ()
139-00-0021

  • General internal orthopaedic fixation system implantation kit
Shannon Helicoidal Ø2.0 x 12 mm
NOVASTEP
CRE12212
In Commercial Distribution

  • 03700879512174 ()
CRE12212

  • Cannulated surgical drill bit, single-use
Retractor
NOVASTEP
XMS01033
In Commercial Distribution

  • 03700879512167 ()
XMS01033

  • General internal orthopaedic fixation system implantation kit
Ø4.9 counterboring single-use
NOVASTEP
XRE01008D
In Commercial Distribution

  • 03700879512105 ()
XRE01008D

  • Cannulated surgical drill bit, single-use
spheric positionning pin Single use
NOVASTEP
XPP01003D
In Commercial Distribution

  • 03700879512051 ()
XPP01003D

  • Orthopaedic intraoperative positioning pin, single-use
drill bit Ø1.8 Single use
NOVASTEP
XDB01020D
In Commercial Distribution

  • 03700879512044 ()
XDB01020D

  • Cannulated surgical drill bit, single-use
Cortical screw Ø2 lg20
NOVASTEP
SP032020
In Commercial Distribution

  • 03700879512013 ()
SP032020

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg18
NOVASTEP
SP032018
In Commercial Distribution

  • 03700879512006 ()
SP032018

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg16
NOVASTEP
SP032016
In Commercial Distribution

  • 03700879511993 ()
SP032016

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg14
NOVASTEP
SP032014
In Commercial Distribution

  • 03700879511986 ()
SP032014

  • Orthopaedic bone screw (non-sliding)
Cortical screw Ø2 lg12
NOVASTEP
SP032012
In Commercial Distribution

  • 03700879511979 ()
SP032012

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg22
NOVASTEP
SP012522
In Commercial Distribution

  • 03700879511962 ()
SP012522

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg20
NOVASTEP
SP012520
In Commercial Distribution

  • 03700879511955 ()
SP012520

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg18
NOVASTEP
SP012518
In Commercial Distribution

  • 03700879511948 ()
SP012518

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg16
NOVASTEP
SP012516
In Commercial Distribution

  • 03700879511931 ()
SP012516

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg14
NOVASTEP
SP012514
In Commercial Distribution

  • 03700879511924 ()
SP012514

  • Orthopaedic bone screw (non-sliding)
Tray
NOVASTEP
ACC1001P0019
In Commercial Distribution

  • 03700879511566 ()
ACC1001P0019

  • Device sterilization/disinfection container, reusable
K-wire Ø1.4 lg150 TR/RD CoCr
NOVASTEP
CKW02005
In Commercial Distribution

  • 03700879511559 ()
CKW02005

  • Orthopaedic intraoperative positioning pin, single-use
Single Use Instrumentation Kit – Arcad 25
NOVASTEP
SUI08006
Not in Commercial Distribution

  • 03700879511542 ()
SUI08006

  • General internal orthopaedic fixation system implantation kit
Single Use Instrumentation Kit – Arcad 20
NOVASTEP
SUI08005
Not in Commercial Distribution

  • 03700879511535 ()
SUI08005

  • General internal orthopaedic fixation system implantation kit
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