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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 Titan Humeral Resurfacing Arthroplasty system is intended for resurfacing of the humeral head due to non-inflammatory or inflammatory arthritis, mild or moderate humeral head deformity and/or limited motion, post-traumatic arthritis, and patients with an intact or reparable rotator cuff. The set includes HRA trials to evaluate the size and fit of the appropriate implant, as well as sizers to determine the amount of bone resection needed for the implant. Instruments are also included to assist with the trials.
Ascension Orthopedics, Inc.
HRARTHIMP
Not in Commercial Distribution

  • M268HRARTHIMP1 ()
  • 10381780234975 ()

  • 22.4 in L x 10.8 in W x 6.3 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint for rheumatoid, degenerative, or post traumatic arthritis. The set includes head and stem trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.
Ascension Orthopedics, Inc.
FRSTDRUJINSP
Not in Commercial Distribution

  • M268FRSTDRUJINSP1 ()
  • 10381780234951 ()

  • 23.0 in L x 11.5 in W x 4.25 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The glenoid tray includes keeled and pegged glenoid trials to evaluate the size and fit of the implant. Round and oval glenoid trials are also included for evaluation. . Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Various instruments are provided to assist with the procedure.
Ascension Orthopedics, Inc.
TSSMINIGLIMP
Not in Commercial Distribution

  • M268TSSMINIGLIMP1 ()
  • 10381780237501 ()

  • 22.3 in L x 9.5 in W x 5.7 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The humeral tray 3 includes keeled and pegged glenoid trials to evaluate the size and fit of the implant. Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Various instruments are provided to assist with the procedure.
Ascension Orthopedics, Inc.
TSS3IMP
Not in Commercial Distribution

  • M268TSS3IMP1 ()
  • 10381780237495 ()

  • 22.6 in L x 10.5 in W x 4.2 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium and titanium alloy with screw diameters from 1.5mm to 1.8mm and lengths from 3.0mm to 5.0mm. The system offers the operating room surgeon unique features and user friendly capabilities. This device is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
INTEGRA LIFESCIENCES CORPORATION
CRANCLOSIMP
Not in Commercial Distribution

  • M268CRANCLOSIMP1 ()
  • 10381780074359 ()

  • 10.16 in L x 4.41 in W x 2.0 in H
CRANCLOSIMP

  • Cranioplasty plate, alterable
The Spider™ and Mini Spider™ Limited Wrist Fusion System consist of two stainless steel plates, featuring an 8-hole and a 6-hole design. Both plates have a unique three-dimensional design optimized for four-corner and other limited wrist fusion procedures.
Ascension Orthopedics, Inc.
SPIDERSET
Not in Commercial Distribution

  • M268SPIDERSET0 ()
  • 10381780064329 ()

  • 14.9 in L x 9.9 in W x 1.9 in H
SPIDERSET

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The rubber wire and half pin stopper coin is used in conjunction with the Integra External Fixation System.
Ascension Orthopedics, Inc.
12224220
In Commercial Distribution

  • 10381780125167 ()

  • 1.08 in L x .90 in W x .354 in H
12224220

  • External orthopaedic fixation system, reusable
Self-Retaining Drill Adaptor
Ascension Orthopedics, Inc.
ADP-0980-105-00
In Commercial Distribution

  • M269ADP0980105001 ()
  • 10381780258667 ()

  • 8.13 in L x .275 in dia


  • Orthopaedic implant-instrument extension adaptor, reusable
Hudson T-Handle
Ascension Orthopedics, Inc.
HDL-0926-002
In Commercial Distribution

  • M269HDL09260021 ()
  • 10381780258339 ()

  • 5.20 in L x 4.50 in W


  • Orthopaedic implant-instrument extension adaptor, reusable
The guidewire is used as a guide for placement or insertion of a device.
Ascension Orthopedics, Inc.
GDW-0926-001
In Commercial Distribution

  • M269GDW09260011 ()
  • 10381780258315 ()

  • 8.5 in L x .11 in dia


  • Orthopaedic guidewire, reusable
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