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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 SEGMENTAL STEM 11MM X 152MM
ONKOS SURGICAL, INC.
25100011E
In Commercial Distribution

  • B27825100011E0 ()
25100011E

  • General internal orthopaedic fixation system implantation kit
TRIAL DISTAL FEMUR
ONKOS SURGICAL, INC.
25100005E
In Commercial Distribution

  • B27825100005E0 ()
25100005E

  • General internal orthopaedic fixation system implantation kit
TRIAL PROXIMAL FEMUR
ONKOS SURGICAL, INC.
25100001E
In Commercial Distribution

  • B27825100001E0 ()
25100001E

  • 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
VARUS/VALGUS TIBIAL RESECTION GUIDE
ONKOS SURGICAL, INC.
K0040040E
In Commercial Distribution

  • B278K0040040E0 ()
K0040040E

  • General internal orthopaedic fixation system implantation kit
RESURFACING PATELLA PEG DRILL
ONKOS SURGICAL, INC.
K0031013E
In Commercial Distribution

  • B278K0031013E0 ()
K0031013E

  • General internal orthopaedic fixation system implantation kit
RESURFACING PATELLA PEG DRILL GUIDE
ONKOS SURGICAL, INC.
K0031002E
In Commercial Distribution

  • B278K0031002E0 ()
K0031002E

  • General internal orthopaedic fixation system implantation kit
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