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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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InTess Lumbar Cage - B07312K0105010

Implant Inserter, 11-13mm, Sleeved
Kalitec Direct LLC
12-K01-0501
In Commercial Distribution

  • B07312K0105010 ()


  • Orthopaedic implant driver

CosmoLock Pedicle Screw System - B07311K0140070

T-Handle, T30, Locking Cap Adjuster
Kalitec Direct LLC
11-K01-4007
In Commercial Distribution

  • B07311K0140070 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0140040

Driver Shaft, T30 Split Tip Double End Cap Starter
Kalitec Direct LLC
11-K01-4004
In Commercial Distribution

  • B07311K0140040 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0120240

Screwdriver, Extended Tab, Cannulated, SNI 1, Lockable, Assembly
Kalitec Direct LLC
11-K01-2024
In Commercial Distribution

  • B07311K0120240 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0120230

Screwdriver, Extended Tab, Fixed Tap Sleeve, Assembly
Kalitec Direct LLC
11-K01-2023
In Commercial Distribution

  • B07311K0120230 ()


  • Surgical screwdriver, reusable

Cosmolock - B07311K0120210

Assembly, Screwdriver, Extended Tab, Cannulated, Lockable
Kalitec Direct LLC
11-K01-2021
In Commercial Distribution

  • B07311K0120210 ()
11-K01-2021

  • Surgical screwdriver, reusable

Cosmolock - B07311K0120150

Assembly, Screwdriver, Polyaxial, Lockable
Kalitec Direct LLC
11-K01-2015
In Commercial Distribution

  • B07311K0120150 ()
11-K01-2015

  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0120130

Screwdriver, Polyaxial, Standard, Fixed Tap Sleeve Assembly
Kalitec Direct LLC
11-K01-2013
In Commercial Distribution

  • B07311K0120130 ()


  • Surgical screwdriver, reusable

Cosmolock - B07311K0120110

Assembly, Screwdriver, Polyaxial, Cannulated, Lockable
Kalitec Direct LLC
11-K01-2011
In Commercial Distribution

  • B07311K0120110 ()
11-K01-2011

  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0120020

T-Handle, T25, Screw Height Adjuster
Kalitec Direct LLC
11-K01-2002
In Commercial Distribution

  • B07311K0120020 ()


  • Surgical screwdriver, reusable
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