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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Lisfranc T plate short
NOVASTEP
PL050101
In Commercial Distribution

  • 03700879510644 ()
PL050101

  • Orthopaedic fixation plate, non-bioabsorbable
Nexis Ø5-Ø7 Complete Kit
NOVASTEP
XTR10023
In Commercial Distribution

  • 03700879510033 ()
XTR10023

  • General internal orthopaedic fixation system implantation kit
Bone Wedge sizer tray
NOVASTEP
ACC1002P0007
In Commercial Distribution

  • 03700879509983 ()
ACC1002P0007

  • Device sterilization/disinfection container, reusable
plate trial holder
NOVASTEP
ACC1006P0005
Not in Commercial Distribution

  • 03700879509846 ()
ACC1006P0005

  • Device sterilization/disinfection container, reusable
Ruler length 150
NOVASTEP
XGA01009
In Commercial Distribution

  • 03700879509839 ()
XGA01009

  • Surgical implant template, reusable
K-wire Ø0.9 lg80 TR/TR CoCr
NOVASTEP
CKW02002
In Commercial Distribution

  • 03700879509822 ()
CKW02002

  • Orthopaedic intraoperative positioning pin, single-use
K-wire Ø0.9 lg80 TR/RD CoCr
NOVASTEP
CKW02001
In Commercial Distribution

  • 03700879509815 ()
CKW02001

  • Orthopaedic intraoperative positioning pin, single-use
Single Use Instrumentation Kit - Benders
NOVASTEP
SUI05001
Not in Commercial Distribution

  • 03700879509792 ()
SUI05001

  • General internal orthopaedic fixation system implantation kit
Adaptator tri-flat male-1/4 Hex cannulated
NOVASTEP
XHA01007
In Commercial Distribution

  • 03700879509778 ()
XHA01007

  • Surgical screwdriver, reusable
T25 large AO screwdriver tip
NOVASTEP
XSD06003
In Commercial Distribution

  • 03700879509761 ()
XSD06003

  • Surgical screwdriver, reusable
E-Wedge sizer 12
NOVASTEP
XMS01021
Not in Commercial Distribution

  • 03700879509754 ()
XMS01021

  • General internal orthopaedic fixation system implantation kit
E-Wedge sizer 10
NOVASTEP
XMS01020
Not in Commercial Distribution

  • 03700879509747 ()
XMS01020

  • General internal orthopaedic fixation system implantation kit
E-Wedge sizer 8
NOVASTEP
XMS01019
Not in Commercial Distribution

  • 03700879509730 ()
XMS01019

  • General internal orthopaedic fixation system implantation kit
E-Wedge sizer 6
NOVASTEP
XMS01018
Not in Commercial Distribution

  • 03700879509723 ()
XMS01018

  • General internal orthopaedic fixation system implantation kit
C-Wedge sizer 8
NOVASTEP
XMS01017
Not in Commercial Distribution

  • 03700879509716 ()
XMS01017

  • General internal orthopaedic fixation system implantation kit
C-Wedge sizer 7
NOVASTEP
XMS01016
Not in Commercial Distribution

  • 03700879509709 ()
XMS01016

  • General internal orthopaedic fixation system implantation kit
C-Wedge sizer 6
NOVASTEP
XMS01015
Not in Commercial Distribution

  • 03700879509693 ()
XMS01015

  • General internal orthopaedic fixation system implantation kit
C-Wedge sizer 5
NOVASTEP
XMS01014
Not in Commercial Distribution

  • 03700879509686 ()
XMS01014

  • General internal orthopaedic fixation system implantation kit
Wedge Handle
NOVASTEP
XMS01013
Not in Commercial Distribution

  • 03700879509679 ()
XMS01013

  • General internal orthopaedic fixation system implantation kit
Bone Wedge impactor
NOVASTEP
XMS01012
Not in Commercial Distribution

  • 03700879509662 ()
XMS01012

  • General internal orthopaedic fixation system implantation kit
Lync DIP
NOVASTEP
CM010040
Not in Commercial Distribution

  • 03700879509655 ()
CM010040

  • Phalangeal joint arthrodesis implant
Lync S10
NOVASTEP
CM010031
Not in Commercial Distribution

  • 03700879509648 ()
CM010031

  • Phalangeal joint arthrodesis implant
Lync S0
NOVASTEP
CM010030
Not in Commercial Distribution

  • 03700879509631 ()
CM010030

  • Phalangeal joint arthrodesis implant
Nexis headed screw Ø2,9 Reamer single-use
NOVASTEP
XRE01013D
Not in Commercial Distribution

  • 03700879509587 ()
XRE01013D

  • General internal orthopaedic fixation system implantation kit
Nexis headed screw Ø2,3 Reamer single-use
NOVASTEP
XRE01012D
Not in Commercial Distribution

  • 03700879509570 ()
XRE01012D

  • General internal orthopaedic fixation system implantation kit
Fraise vis headed Ø2,9
NOVASTEP
XRE01013
Not in Commercial Distribution

  • 03700879509563 ()
XRE01013

  • General internal orthopaedic fixation system implantation kit
Single Use Instrumentation Kit - Airlock Utility Trial Implants
NOVASTEP
SUI03004
Not in Commercial Distribution

  • 03700879509549 ()
SUI03004

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Single Use Instrumentation Kit - Airlock Lapidus Trial Implants
NOVASTEP
SUI03003
Not in Commercial Distribution

  • 03700879509532 ()
SUI03003

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Single Use Instrumentation Kit - Airlock MT base Trial Implants
NOVASTEP
SUI03002
Not in Commercial Distribution

  • 03700879509525 ()
SUI03002

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Single Use Instrumentation Kit - Airlock MTP Trial Implants
NOVASTEP
SUI03001
Not in Commercial Distribution

  • 03700879509518 ()
SUI03001

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Fraise vis headed Ø2,3
NOVASTEP
XRE01012
Not in Commercial Distribution

  • 03700879509501 ()
XRE01012

  • General internal orthopaedic fixation system implantation kit
K-Wire Ø2 lg200 TR/RD
NOVASTEP
CKW01007
Not in Commercial Distribution

  • 03700879509495 ()
CKW01007

  • Orthopaedic intraoperative positioning pin, single-use
K-Wire Ø1 lg150 TR/RD
NOVASTEP
CKW01006
Not in Commercial Distribution

  • 03700879509488 ()
CKW01006

  • Orthopaedic intraoperative positioning pin, single-use
Percutaneous rasps
NOVASTEP
XMS01009
In Commercial Distribution

  • 03700879509471 ()
XMS01009

  • General internal orthopaedic fixation system implantation kit
NEXIS Screw Ø2.9 Fully Threaded length 48
NOVASTEP
TS020048
Not in Commercial Distribution

  • 03700879509457 ()
TS020048

  • Bone-nailing compression screw
NEXIS Screw Ø2.9 Fully Threaded length 46
NOVASTEP
TS020046
Not in Commercial Distribution

  • 03700879509433 ()
TS020046

  • Bone-nailing compression screw
NEXIS Screw Ø2.9 Fully Threaded length 44
NOVASTEP
TS020044
Not in Commercial Distribution

  • 03700879509419 ()
TS020044

  • Bone-nailing compression screw
NEXIS Screw Ø2.9 Fully Threaded length 42
NOVASTEP
TS020042
Not in Commercial Distribution

  • 03700879509396 ()
TS020042

  • Bone-nailing compression screw
NEXIS Screw Ø2.9 Fully Threaded length 40
NOVASTEP
TS020040
Not in Commercial Distribution

  • 03700879509372 ()
TS020040

  • Bone-nailing compression screw
NEXIS Screw Ø2.9 Fully Threaded length 38
NOVASTEP
TS020038
Not in Commercial Distribution

  • 03700879509358 ()
TS020038

  • Bone-nailing compression screw
NEXIS Screw Ø2.9 Fully Threaded length 36
NOVASTEP
TS020036
Not in Commercial Distribution

  • 03700879509334 ()
TS020036

  • Bone-nailing compression screw
Shannon Larga Ø3.0 x 20 mm
NOVASTEP
CRE13020
In Commercial Distribution

  • 03700879509297 ()
CRE13020

  • Cannulated surgical drill bit, single-use
Shannon Corta Ø2 x 8mm sterile
NOVASTEP
CRE12008
In Commercial Distribution

  • 03700879509273 ()
CRE12008

  • Cannulated surgical drill bit, single-use
Reamers-Benders module
NOVASTEP
ACC1002P0006
In Commercial Distribution

  • 03700879509242 ()
ACC1002P0006

  • Device sterilization/disinfection container, reusable
Perioestal elevator single tip
NOVASTEP
XMS01011
In Commercial Distribution

  • 03700879509099 ()
XMS01011

  • General internal orthopaedic fixation system implantation kit
Module
NOVASTEP
ACC1001P0016
In Commercial Distribution

  • 03700879509082 ()
ACC1001P0016

  • Device sterilization/disinfection container, reusable
Foret Nexis canulé Ø1,95 FT
NOVASTEP
XDB01013
Not in Commercial Distribution

  • 03700879509044 ()
XDB01013

  • General internal orthopaedic fixation system implantation kit
Nexis Ø2,9 FT Ruler
NOVASTEP
XGA01008
Not in Commercial Distribution

  • 03700879509037 ()
XGA01008

  • General internal orthopaedic fixation system implantation kit
Closed Arms Distractor
NOVASTEP
XFP01006
In Commercial Distribution

  • 03700879509013 ()
XFP01006

  • General internal orthopaedic fixation system implantation kit
NEXIS Screw Ø2.9 Fully Threaded length 34
NOVASTEP
TS020034
Not in Commercial Distribution

  • 03700879508566 ()
TS020034

  • Bone-nailing compression screw
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