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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
141014ND
Not in Commercial Distribution

  • M248141014ND1 ()
  • 10381780048206 ()

  • 14mm diameter
141014ND

  • 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
141013ND
Not in Commercial Distribution

  • M248141013ND1 ()
  • 10381780048190 ()

  • 13mm diameter
141013ND

  • 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
141012ND
Not in Commercial Distribution

  • M248141012ND1 ()
  • 10381780048183 ()

  • 12mm diameter
141012ND

  • 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
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 Newdeal sterile Compression Plate consists of a plate, available in different sizes, and is implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
330430SND
In Commercial Distribution

  • 10381780044406 ()
  • M248330430SND1 ()

  • 38.3mm length x 17.3mm width x 30mm interaxis
330430SND

  • Orthopaedic fixation plate, non-bioabsorbable
The Newdeal sterile Compression Plate consists of a plate, available in different sizes, and is implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
330425SND
In Commercial Distribution

  • 10381780044390 ()
  • M248330425SND1 ()

  • 33.3mm length x 17.3mm width x 25mm interaxis
330425SND

  • Orthopaedic fixation plate, non-bioabsorbable
The Newdeal sterile Compression Plate consists of a plate, available in different sizes, and is implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
330420SND
In Commercial Distribution

  • 10381780044383 ()
  • M248330420SND1 ()

  • 28.3mm length x 17.3mm width x 20mm interaxis
330420SND

  • Orthopaedic fixation plate, non-bioabsorbable
The Newdeal sterile Compression Plate consists of a plate, available in different sizes, and is implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
330230SND
In Commercial Distribution

  • 10381780044376 ()
  • M248330230SND1 ()

  • 41mm length x 8.3mm width x 30mm interaxis
330230SND

  • Orthopaedic fixation plate, non-bioabsorbable
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