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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Bunion implant Ø3 lg26
NOVASTEP
PS020026
In Commercial Distribution

  • 03700879510040 ()
PS020026

  • Orthopaedic bone screw (non-sliding)
plate trial holder
NOVASTEP
ACC1006P0005
Not in Commercial Distribution

  • 03700879509846 ()
ACC1006P0005

  • Device sterilization/disinfection container, reusable
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
Single Use Instrumentation Kit - Airlock MTP Trial Implants
NOVASTEP
SUI03001
Not in Commercial Distribution

  • 03700879509518 ()
SUI03001

  • Orthopaedic surgical procedure kit, non-medicated, single-use
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 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
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