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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 Size Device Size Type Device Class Implantable

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TRIAL STEM EXTENSION 17X100MM
ONKOS SURGICAL, INC.
K0050017E
In Commercial Distribution

  • B278K0050017E0 ()
K0050017E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 16X100MM
ONKOS SURGICAL, INC.
K0050016E
In Commercial Distribution

  • B278K0050016E0 ()
K0050016E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 15X100MM
ONKOS SURGICAL, INC.
K0050015E
In Commercial Distribution

  • B278K0050015E0 ()
K0050015E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 14X100MM
ONKOS SURGICAL, INC.
K0050014E
In Commercial Distribution

  • B278K0050014E0 ()
K0050014E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 13X100MM
ONKOS SURGICAL, INC.
K0050013E
In Commercial Distribution

  • B278K0050013E0 ()
K0050013E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 12X100MM
ONKOS SURGICAL, INC.
K0050012E
In Commercial Distribution

  • B278K0050012E0 ()
K0050012E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 11X100MM
ONKOS SURGICAL, INC.
K0050011E
In Commercial Distribution

  • B278K0050011E0 ()
K0050011E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 10X100MM
ONKOS SURGICAL, INC.
K0050010E
In Commercial Distribution

  • B278K0050010E0 ()
K0050010E

  • General internal orthopaedic fixation system implantation kit
IM TIBIAL RESECTION GUIDE
ONKOS SURGICAL, INC.
K0041010E
In Commercial Distribution

  • B278K0041010E0 ()
K0041010E

  • General internal orthopaedic fixation system implantation kit
IM TIBIAL ALIGNMENT GUIDE
ONKOS SURGICAL, INC.
K0041000E
In Commercial Distribution

  • B278K0041000E0 ()
K0041000E

  • General internal orthopaedic fixation system implantation kit
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