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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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Fenestrated pedicle screw (oncology)
CARBOFIX ORTHOPEDICS LTD
Pedicle Screw - Fenestrated
In Commercial Distribution

  • 17290117350284 ()
  • 07290117350287 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter
PNNSC6540FN

  • Spinal bone screw, non-bioabsorbable
Fenestrated pedicle screw (oncology)
CARBOFIX ORTHOPEDICS LTD
Pedicle Screw - Fenestrated
In Commercial Distribution

  • 17290117350277 ()
  • 07290117350270 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter
PNNSC6535FN

  • Spinal bone screw, non-bioabsorbable
Pedicle Screw Navigated Screwdriver for use with the CarboClear X Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Navigated Screwdriver
In Commercial Distribution

  • 07290117350065 ()
PPS922162N

  • Surgical screwdriver, reusable
An adaptor for the Pedicle Screw Navigated Screwdriver for use with the CarboClear X Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Navigated Screwdriver Adaptor
In Commercial Distribution

  • 07290117350058 ()
PPS922163N

  • Surgical screwdriver, reusable
Set Screw Starter for use with the CarboClear X Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Set Screw Starter
In Commercial Distribution

  • 07290117350041 ()
PPS922790G2

  • Surgical screwdriver, reusable
Handle for use with the Rod Reducer of the CarboClear X Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Rod Reducer Handle
In Commercial Distribution

  • 07290117350034 ()
PPS922781G2

  • Surgical instrument handle, non-torque-limiting
Counter-torque for use with the CarboClear X Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Counter-torque
In Commercial Distribution

  • 07290117350027 ()
PPS922540G2

  • Orthopaedic counter-torque/rod-pushing instrument
Set Screw Locker for use with the CarboClear X Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Set Screw Locker
In Commercial Distribution

  • 07290117350010 ()
PPS922460G2

  • Surgical screwdriver, reusable
Tulip Adjuster for use with the CarboClear X Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Rod Reducer
In Commercial Distribution

  • 07290117350003 ()
PPS922440G2

  • Orthopaedic counter-torque/rod-pushing instrument
CarboClear X Dual Thread Pedicle Screw Fenestrated
CARBOFIX ORTHOPEDICS LTD
Pedicle Screw - Dual Thread
In Commercial Distribution

  • 17290117355784 ()
  • 07290117355787 ()

  • Length: 30 Millimeter
  • Outer Diameter: 6.5 Millimeter
XDT6530F

  • Spinal bone screw, non-bioabsorbable
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