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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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Integra® Spider™ Limted Wrist Fusion System - 10381780064756

The Mini Integra Spider Limited Wrist Fusion stainless steel plate includes six-holes and can be utilized in various locations throughout the wrist.
Ascension Orthopedics, Inc.
070006
In Commercial Distribution

  • M2480700061 ()
  • 10381780064756 ()

  • .549 in dia x .15 in L
070006

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

Integra® Spider™ Limted Wrist Fusion System - 10381780064664

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

Integra® Total Wrist Fusion System - 10381780064350

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

Universal 2™ Total Wrist System - 10381780064336

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

Integra® Proximal Humeral Fracture Plate System - 10381780121251

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3575LS
In Commercial Distribution

  • 10381780121251 ()
  • M269PSS3575LS1 ()

  • 3.061 in L x .138 in dia
PSS3575LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable

Integra® Proximal Humeral Fracture Plate System - 10381780121244

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3570LS
In Commercial Distribution

  • M269PSS3570LS1 ()
  • 10381780121244 ()

  • 2.864 in L x .138 in dia
PSS3570LS

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

Integra® Proximal Humeral Fracture Plate System - 10381780121237

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3565LS
In Commercial Distribution

  • M269PSS3565LS1 ()
  • 10381780121237 ()

  • 2.667 in L x .138 in dia
PSS3565LS

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

Integra® Proximal Humeral Fracture Plate System - 10381780121220

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3560LS
In Commercial Distribution

  • M269PSS3560LS1 ()
  • 10381780121220 ()

  • 2.470 in L x .138 in dia
PSS3560LS

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

Integra® Proximal Humeral Fracture Plate System - 10381780121213

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3555LS
In Commercial Distribution

  • M269PSS3555LS1 ()
  • 10381780121213 ()

  • 2.273 in L x .138 in dia
PSS3555LS

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

Integra® Proximal Humeral Fracture Plate System - 10381780121206

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3550LS
In Commercial Distribution

  • M269PSS3550LS1 ()
  • 10381780121206 ()

  • 2.077 in L x .138 in dia
PSS3550LS

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