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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 Integra External Fixation System anterior half ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224104
In Commercial Distribution

  • 10381780125488 ()

  • 160 mm inner dia
12224104

  • External orthopaedic fixation system, reusable
The Integra External Fixation System half ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224103
In Commercial Distribution

  • 10381780125471 ()

  • 160 mm inner dia
12224103

  • External orthopaedic fixation system, reusable
The Integra External Fixation System full ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224102
In Commercial Distribution

  • 10381780125464 ()

  • 160 mm inner dia
12224102

  • External orthopaedic fixation system, reusable
The Integra External Fixation System 5/8 ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224101
In Commercial Distribution

  • 10381780125457 ()

  • 160 mm inner dia
12224101

  • External orthopaedic fixation system, reusable
The Integra External Fixation System footplate is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224100
In Commercial Distribution

  • 10381780125440 ()

  • 160 mm inner dia
12224100

  • External orthopaedic fixation system, reusable
The universal joint is made from stainless steel. It is used to aid in the assembly of the Integra External Fixation System.
Ascension Orthopedics, Inc.
12225221
In Commercial Distribution

  • 10381780125433 ()

  • 1.28 in L
12225221

  • External orthopaedic fixation system, reusable
The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features two distal ends which are designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.
Ascension Orthopedics, Inc.
12225220
Not in Commercial Distribution

  • 10381780125426 ()

  • Long: 180 - 230mm L
12225220

  • External orthopaedic fixation system, reusable
The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features one distal end which is designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.
Ascension Orthopedics, Inc.
12225210
Not in Commercial Distribution

  • 10381780125419 ()

  • Medium: 140 - 180mm L
12225210

  • External orthopaedic fixation system, reusable
The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features a tightened mode which allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.
Ascension Orthopedics, Inc.
12225200
Not in Commercial Distribution

  • 10381780125402 ()

  • Short: 95 - 140mm L
12225200

  • External orthopaedic fixation system, reusable
The threaded rod is used to connect and support rings in the construct. The rod is made from stainless steel.
Ascension Orthopedics, Inc.
12224245
In Commercial Distribution

  • 10381780125396 ()

  • 200 mm L
12224245

  • External orthopaedic fixation system, reusable
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