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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 BLOCK AUGMENT 5MM, SIZE 2
ONKOS SURGICAL, INC.
K0053015E
In Commercial Distribution

  • B278K0053015E0 ()
K0053015E

  • General internal orthopaedic fixation system implantation kit
TRIAL BLOCK AUGMENT 5MM, SIZE 1
ONKOS SURGICAL, INC.
K0053014E
In Commercial Distribution

  • B278K0053014E0 ()
K0053014E

  • General internal orthopaedic fixation system implantation kit
TRIAL BLOCK AUGMENT 5MM, SIZE 1
ONKOS SURGICAL, INC.
K0053013E
In Commercial Distribution

  • B278K0053013E0 ()
K0053013E

  • General internal orthopaedic fixation system implantation kit
REVISION BLOCK AUGMENT RESECTION GUIDE LEFT
ONKOS SURGICAL, INC.
K0052003E
In Commercial Distribution

  • B278K0052003E0 ()
K0052003E

  • General internal orthopaedic fixation system implantation kit
REVISION BLOCK AUGMENT RESECTION GUIDE RIGHT
ONKOS SURGICAL, INC.
K0052002E
In Commercial Distribution

  • B278K0052002E0 ()
K0052002E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 15X30MM
ONKOS SURGICAL, INC.
K0051530E
In Commercial Distribution

  • B278K0051530E0 ()
K0051530E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 20X140MM
ONKOS SURGICAL, INC.
K0051420E
In Commercial Distribution

  • B278K0051420E0 ()
K0051420E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 18X140MM
ONKOS SURGICAL, INC.
K0051418E
In Commercial Distribution

  • B278K0051418E0 ()
K0051418E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 17X140MM
ONKOS SURGICAL, INC.
K0051417E
In Commercial Distribution

  • B278K0051417E0 ()
K0051417E

  • General internal orthopaedic fixation system implantation kit
TRIAL STEM EXTENSION 16X140MM
ONKOS SURGICAL, INC.
K0051416E
In Commercial Distribution

  • B278K0051416E0 ()
K0051416E

  • General internal orthopaedic fixation system implantation kit
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