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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 - B07312K0105050

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

  • B07312K0105050 ()


  • Orthopaedic implant driver

InTess Lumbar Cage - B07312K0105040

Implant Inserter, 11-13mm, Sleeveless
Kalitec Direct LLC
12-K01-0504
In Commercial Distribution

  • B07312K0105040 ()


  • 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 - B07312K0105020

Implant Inserter, 14-16mm, Sleeved
Kalitec Direct LLC
12-K01-0502
In Commercial Distribution

  • B07312K0105020 ()


  • Orthopaedic implant driver

InTess Lumbar Cage - B07312K0105010

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

  • B07312K0105010 ()


  • 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

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
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