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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 Spider Limited Wrist Fusion stainless steel plate includes eight-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
070005
In Commercial Distribution

  • M2480700051 ()
  • 10381780064749 ()

  • .640 in dia x .150 in L
070005

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Mini Integra Spider Limited Wrist Fusion titanium plate includes six-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
060006
In Commercial Distribution

  • M2480600061 ()
  • 10381780064664 ()

  • .549 in dia x .15 in L
060006

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Integra Spider Limited Wrist Fusion titanium plate includes eight-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
060005
In Commercial Distribution

  • M2480600051 ()
  • 10381780064657 ()

  • .64 in dia. x .15 in L
060005

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nine holes. These plates are fixed to the bone with 2.7mm diameter and 3.5mm diameter screws. Instrumentation is provided to assist in the implantation. Screws with a diameter of 2.7mm vary in size length from 10mm to 24mm. Screws with a diameter of 3.5mm vary in size length from 12mm to 28mm. This system is generally indicated for use in patients with arthritis of the joints of the wrist, rheumatoid wrist deformities, carpal instability, wrist pain, brachial plexus nerve palsies, and loss of function due to osteoarthritis.
INTEGRA LIFESCIENCES CORPORATION
WRISTFUSESET
Not in Commercial Distribution

  • M268WRISTFUSESET0 ()
  • 10381780064350 ()

  • 20.10 in L x 10.84 in W
WRISTFUSESET

  • Orthopaedic fixation plate, non-bioabsorbable
The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint, as well as corresponding instrumentation. The radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal. It is manufactured from cast CoCr alloy. The carpal component is a titanium plate which is fixed into the carpal bones with a cemented central peg and two titanium screws. Instrumentation is provided to assist in the surgical implantation.
Ascension Orthopedics, Inc.
UNI2SET
Not in Commercial Distribution

  • M268UNI2SET0 ()
  • 10381780064336 ()

  • 21.5 in L x 10.3 in W
UNI2SET

  • Total wrist prosthesis
The Integra External Fixation System two-post bridge is manufactured from stainless steel. 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.
12225223
Not in Commercial Distribution

  • 10381780125679 ()

  • 1.116 in L x 1.107 in W
12225223

  • External orthopaedic fixation system, reusable
A rockerbottom is attached to the bottom of the external device so that the patient may stand on it if needed. It is manufactured from aluminum and silicone rubber.
Ascension Orthopedics, Inc.
12225400
In Commercial Distribution

  • 10381780125563 ()

  • 10.71 in L x 10.11 in W
12225400

  • External orthopaedic fixation system, reusable
The k-wire washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel.
Ascension Orthopedics, Inc.
12220025
In Commercial Distribution

  • 10381780124986 ()

  • .394 in dia x .039 in H
12220025

  • External orthopaedic fixation system, reusable
The Integra External Fixation System k-wires are manufactured from stainless steel and are secured to the bone segment. They are 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. The olive wire is designed to include an oval area on the wire for alignment to a washer.
Ascension Orthopedics, Inc.
12220024
In Commercial Distribution

  • 10381780124979 ()

  • 20.87 in L x .079 in dia
12220024

  • External orthopaedic fixation system, reusable
The Integra External Fixation System k-wires are manufactured from stainless steel and are secured to the bone segment. They are 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. The olive wire is designed to include an oval area on the wire for alignment to a washer.
Ascension Orthopedics, Inc.
12220023
In Commercial Distribution

  • 10381780124962 ()

  • 15.75 in L x .079 in dia
12220023

  • External orthopaedic fixation system, reusable
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