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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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Implant PEEK CC Wedge, 10mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-2525-10
In Commercial Distribution

  • 00810005669313 ()

  • Width: 25 Millimeter
  • Depth: 25 Millimeter
  • 10mm Thick


  • Polymeric osteotomy fusion cage, non-customized
Implant PEEK CC Wedge, 8mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-2525-08
In Commercial Distribution

  • 00810005669306 ()

  • Width: 25 Millimeter
  • Depth: 25 Millimeter
  • 8mm Thick


  • Polymeric osteotomy fusion cage, non-customized
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901350
In Commercial Distribution

  • 00841549107351 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901349
In Commercial Distribution

  • 00841549107344 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901348
In Commercial Distribution

  • 00841549107337 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901347
In Commercial Distribution

  • 00841549107320 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901346
In Commercial Distribution

  • 00841549107313 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901345
In Commercial Distribution

  • 00841549107306 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901344
In Commercial Distribution

  • 00841549107290 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901343
In Commercial Distribution

  • 00841549107283 ()


  • Screw endosteal dental implant, two-piece
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