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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 Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. They are 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. All plates and screws are manufactured from titanium alloy. The left lateral anterior tibial plate is delivered non sterile.
NEWDEAL
150020ND
In Commercial Distribution

  • M248150020ND1 ()
  • 10381780043713 ()

  • 92.7mm length x 19.9mm width
150020ND

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. They are 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. All plates and screws are manufactured from titanium alloy. The left medial anterior tibial plate is delivered non sterile.
NEWDEAL
150010ND
In Commercial Distribution

  • 10381780043690 ()
  • M248150010ND1 ()

  • 77mm length x 16mm width
150010ND

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Hallu-Lock plate system is a low profile titanium plate dedicated to the first metatarsophalangeal arthrodesis. This system includes Hallu-Lock C plates, Hallu-Lock S plates, screws, and instruments. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.
NEWDEAL
HALULCKIMP
Not in Commercial Distribution

  • 10381780064473 ()
  • M248HALULCKIMP1 ()
HALULCKIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. The system is indicated for fixation of bone fractures or bone reconstruction. Instruments are provided for guidance of implants.
NEWDEAL
TIBIAXYSSET
Not in Commercial Distribution

  • 10381780064466 ()
  • M248TIBIAXYSSET1 ()
TIBIAXYSSET

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. 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
286340SND
Not in Commercial Distribution

  • M248286340SND1 ()
  • 10381780057604 ()

  • 3.5mm diam. x 40mm length


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. 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
286340ND
Not in Commercial Distribution

  • M248286340ND1 ()
  • 10381780057598 ()

  • 3.5mm diam. x 40mm length


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. 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
286338SND
Not in Commercial Distribution

  • M248286338SND1 ()
  • 10381780057581 ()

  • 3.5mm diam. x 38mm length


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. 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
286338ND
Not in Commercial Distribution

  • M248286338ND1 ()
  • 10381780057574 ()

  • 3.5mm diam. x 38mm length


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. 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
286336SND
Not in Commercial Distribution

  • M248286336SND1 ()
  • 10381780057567 ()

  • 3.5mm diam. x 36mm length


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. 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
286336ND
Not in Commercial Distribution

  • M248286336ND1 ()
  • 10381780057550 ()

  • 3.5mm diam. x 36mm length


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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