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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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Kinos Axiom Flat Top Talar Implant, Size 4, Right
Restor3d, Inc.
2831.0214
Not in Commercial Distribution

  • 00860007995187 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 3, Right
Restor3d, Inc.
2831.0213
Not in Commercial Distribution

  • 00860007995170 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 2, Right
Restor3d, Inc.
2831.0212
Not in Commercial Distribution

  • 00860007995163 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 1, Right
Restor3d, Inc.
2831.0211
Not in Commercial Distribution

  • 00860007995156 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 5, Left
Restor3d, Inc.
2831.0115
Not in Commercial Distribution

  • 00860007995149 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 4, Left
Restor3d, Inc.
2831.0114
Not in Commercial Distribution

  • 00860007995132 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 3, Left
Restor3d, Inc.
2831.0113
Not in Commercial Distribution

  • 00860007995125 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 2, Left
Restor3d, Inc.
2831.0112
Not in Commercial Distribution

  • 00860007995118 ()


  • Coated ankle tibia prosthesis
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 11B-A
In Commercial Distribution

  • 05712821006318 ()
  • 05712821009227 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 11A-D
In Commercial Distribution

  • 05712821006301 ()
  • 05712821009210 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
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