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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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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

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

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 - B07311K0140030

Cap Starter, T30, Split Tip, Quarter Square
Kalitec Direct LLC
11-K01-4003
In Commercial Distribution

  • B07311K0140030 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0140020

Driver Shaft, T30 No Taper, Final Cap Driver
Kalitec Direct LLC
11-K01-4002
In Commercial Distribution

  • B07311K0140020 ()


  • Surgical screwdriver, reusable

CosmoLock Pedicle Screw System - B07311K0140010

T-Handle, T30 Split Tip Cap Starter
Kalitec Direct LLC
11-K01-4001
In Commercial Distribution

  • B07311K0140010 ()


  • 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
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