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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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NIDO Pedicle Screw System - B07315K0160200

T-Handle, T20 Dominoes Cap Starter
Kalitec Direct LLC
15-K01-6020
In Commercial Distribution

  • B07315K0160200 ()
15-K01-6020

  • Surgical screwdriver, reusable

NIDO Pedicle Screw System - B07315K0140200

T-Handle, T30 Split Tip Cap Starter
Kalitec Direct LLC
15-K01-4020
In Commercial Distribution

  • B07315K0140200 ()
15-K01-4020

  • Surgical screwdriver, reusable

NIDO Pedicle Screw System - B07315K0120200

Screwdriver, Modular Bone Screws
Kalitec Direct LLC
15-K01-2020
In Commercial Distribution

  • B07315K0120200 ()
15-K01-2020

  • Surgical screwdriver, reusable

NIDO Pedicle Screw System - B07315K0120100

Assembly, Screwdriver, NIDO Assembled Screws
Kalitec Direct LLC
15-K01-2010
In Commercial Distribution

  • B07315K0120100 ()
15-K01-2010

  • Surgical screwdriver, reusable

InSePtion MIS Fixation System - B07314K0120500

Inserter, All-In-One
Kalitec Direct LLC
14-K01-2050
In Commercial Distribution

  • B07314K0120500 ()


  • Orthopaedic implant driver

InSePtion MIS Fixation System - B07314K0120200

Inserter, Locking Plate
Kalitec Direct LLC
14-K01-2020
In Commercial Distribution

  • B07314K0120200 ()


  • Orthopaedic implant driver

InSePtion MIS Fixation System - B07314K0120100

Inserter, Core
Kalitec Direct LLC
14-K01-2010
In Commercial Distribution

  • B07314K0120100 ()


  • Orthopaedic implant driver

Navagio - B07330K0112100

Draw Rod, Universal Inline Fixed Inserter
Kalitec Direct LLC
30-K01-1210
In Commercial Distribution

  • B07330K0112100 ()
30-K01-1210

  • Orthopaedic implant driver

Navagio - B07330K0112000

Inserter, Universal Inline Fixed
Kalitec Direct LLC
30-K01-1200
In Commercial Distribution

  • B07330K0112000 ()
30-K01-1200

  • Orthopaedic implant driver

Navagio - B07330K0110000

Inserter, Universal Articulating
Kalitec Direct LLC
30-K01-1000
In Commercial Distribution

  • B07330K0110000 ()
30-K01-1000

  • Orthopaedic implant driver
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