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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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11 IN REAMER/IM ROD
ONKOS SURGICAL, INC.
K0001101E
In Commercial Distribution

  • B278K0001101E0 ()
K0001101E

  • General internal orthopaedic fixation system implantation kit
DRILL BIT 1/8IN X 100MM
ONKOS SURGICAL, INC.
K0001015E
In Commercial Distribution

  • B278K0001015E0 ()
K0001015E

  • General internal orthopaedic fixation system implantation kit
DRILL BIT 1/8 IN
ONKOS SURGICAL, INC.
K0001005E
In Commercial Distribution

  • B278K0001005E0 ()
K0001005E

  • General internal orthopaedic fixation system implantation kit
STARTER DRILL BIT 3/8 IN
ONKOS SURGICAL, INC.
K0001002E
In Commercial Distribution

  • B278K0001002E0 ()
K0001002E

  • General internal orthopaedic fixation system implantation kit
EXTERNAL CHECK ROD
ONKOS SURGICAL, INC.
K0000901E
In Commercial Distribution

  • B278K0000901E0 ()
K0000901E

  • General internal orthopaedic fixation system implantation kit
EXTERNAL CHECK GUIDE
ONKOS SURGICAL, INC.
K0000900E
In Commercial Distribution

  • B278K0000900E0 ()
K0000900E

  • General internal orthopaedic fixation system implantation kit
Bowed Stem Trial 21x152MM
ONKOS SURGICAL, INC.
BT-21152-03N
In Commercial Distribution

  • B278BT2115203N0 ()
BT-21152-03N

  • General internal orthopaedic fixation system implantation kit
Bowed Stem Trial 20x152MM
ONKOS SURGICAL, INC.
BT-20152-03N
In Commercial Distribution

  • B278BT2015203N0 ()
BT-20152-03N

  • General internal orthopaedic fixation system implantation kit
Bowed Stem Trial 19x152MM
ONKOS SURGICAL, INC.
BT-19152-03N
In Commercial Distribution

  • B278BT1915203N0 ()
BT-19152-03N

  • General internal orthopaedic fixation system implantation kit
Bowed Stem Trial 18x152MM
ONKOS SURGICAL, INC.
BT-18152-03N
In Commercial Distribution

  • B278BT1815203N0 ()
BT-18152-03N

  • General internal orthopaedic fixation system implantation kit
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