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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 - 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 - B07314K0140100

Set Screw Driver Shaft, Final Torque, T15
Kalitec Direct LLC
14-K01-4010
In Commercial Distribution

  • B07314K0140100 ()


  • 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

InTess L - B07312K0310170

T-Handle, Fixed, 1/4" Square
Kalitec Direct LLC
12-K03-1017
In Commercial Distribution

  • B07312K0310170 ()
12-K03-1017

  • Surgical torque wrench, reusable

InTess Lumbar Cage - B07312K0105060

Inserter Sleeve, All Size Implants
Kalitec Direct LLC
12-K01-0506
In Commercial Distribution

  • B07312K0105060 ()


  • Orthopaedic implant driver

InTess Lumbar Cage - B07312K0105050

Implant Inserter, 14-16mm, Sleeveless
Kalitec Direct LLC
12-K01-0505
In Commercial Distribution

  • B07312K0105050 ()


  • Orthopaedic implant driver

InTess Lumbar Cage - B07312K0105030

Implant Inserter, 8-10mm, Sleeveless
Kalitec Direct LLC
12-K01-0503
In Commercial Distribution

  • B07312K0105030 ()


  • Orthopaedic implant driver

InTess Lumbar Cage - B07312K0105000

Implant Inserter, 8-10mm, Sleeved
Kalitec Direct LLC
12-K01-0500
In Commercial Distribution

  • B07312K0105000 ()


  • Orthopaedic implant driver

CosmoLock Pedicle Screw System - B07311K0150000

Driver Shaft, T15, Cross Link Final Driver
Kalitec Direct LLC
11-K01-5000
In Commercial Distribution

  • B07311K0150000 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0140110

T-Handle, T30 Split Tip, Extended Assembly
Kalitec Direct LLC
11-K01-4011
In Commercial Distribution

  • B07311K0140110 ()


  • Surgical screwdriver, reusable
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