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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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The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141011ND
Not in Commercial Distribution

  • M248141011ND1 ()
  • 10381780048176 ()

  • 11mm diameter
141011ND

  • Subtalar implant, non-bioabsorbable
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141010ND
Not in Commercial Distribution

  • 10381780048169 ()
  • M248141010ND1 ()

  • 10mm diameter
141010ND

  • Subtalar implant, non-bioabsorbable
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141009ND
Not in Commercial Distribution

  • 10381780048152 ()
  • M248141009ND1 ()

  • 9mm diameter
141009ND

  • Subtalar implant, non-bioabsorbable
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901492
In Commercial Distribution

  • 00841549108266 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901491
In Commercial Distribution

  • 00841549108259 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901489
In Commercial Distribution

  • 00841549108235 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901488
In Commercial Distribution

  • 00841549108228 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901493
In Commercial Distribution

  • 00841549108273 ()


  • Screw endosteal dental implant, one-piece
SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location. SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate. SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.
SurgMark GmbH
SchurSign 1.5-5
In Commercial Distribution

  • 04262491960003 ()
  • 04262491960010 ()


  • Radiological image marker, implantable
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation.The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901490
In Commercial Distribution

  • 00841549108242 ()


  • Screw endosteal dental implant, one-piece
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