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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 Construct Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a major thread diameter of 4.5 or 6.5mm. All plates and screws are manufactured from stainless steel or titanium. The system is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions, and replantation of small bones in the foot and ankle. Instruments are provided.
Ascension Orthopedics, Inc.
AFPIMP
Not in Commercial Distribution

  • M268AFPIMP1 ()
  • 10381780064497 ()
AFPIMP

  • Internal orthopaedic fixation system, plate/screw, 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
The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The Hallu Plates are low profile titanium plates dedicated to first metatarsophalangeal arthrodesis. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.
NEWDEAL
HALUINSTSET
Not in Commercial Distribution

  • 10381780064404 ()
  • M248HALUINSTSET1 ()
HALUINSTSET

  • General internal orthopaedic fixation system implantation kit
In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a greater degree of correction. Due to the leverage effect, the osteotomy site is subject to significant dorsiflexion stress. The B-BOP plate is specifically designed for basal osteotomy of the first metatarsal, with strong stability. The set includes the B-BOP plates, screws, and instruments, including K-wire.
NEWDEAL
BBOPSET
In Commercial Distribution

  • 10381780064381 ()
  • M248BBOPSET1 ()
BBOPSET

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Advansys Midfoof Complete set includes Lisfranc plates, Lapidus plates, screws, and instruments used to guide the implants, including K-wire. The Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is available in different sizes and is implanted using the locking system fixation screws and washers. Lisfranc Plates are intended for fractures, fusions, osteotomies and replantation of small bones at the tarsometatarsal joints. The Lapidus Plate consists of an osteosynthesis plate designed to bridge the first tarometatarsal joint.
NEWDEAL
ADVANMID
In Commercial Distribution

  • 10381780064374 ()
  • M248ADVANMID1 ()
ADVANMID

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Advansys Hindfoot Complete set includes TTC plates, screws for fixation, and instruments to be used as a guide for the implants, including K-wire. The TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantation of small bones in the foot and ankle.
NEWDEAL
ADVANHIND
In Commercial Distribution

  • 10381780064367 ()
  • M248ADVANHIND1 ()
ADVANHIND

  • 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
286310SND
In Commercial Distribution

  • 10381780057543 ()
  • M248286310SND1 ()

  • 3.5mm diam. x 10mm length
286310SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates. Also included are 3.7mm locking screws.
Ascension Orthopedics, Inc.
RFOOTIMP
Not in Commercial Distribution

  • M268RFOOTIMP1 ()
  • 10381780064640 ()
RFOOTIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. . The fore foot and mid foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates. Also included are 2.7mm locking screws.
Ascension Orthopedics, Inc.
FFMFOOTIMP
Not in Commercial Distribution

  • M268FFMFOOTIMP1 ()
  • 10381780064633 ()
FFMFOOTIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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