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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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DigiFuse® Cannulated Intramedullary Fusion System - 10381780244844

Integra® DigiFuse® The smooth guide wire is used as a guide for placement or insertion of a device.
Ascension Orthopedics, Inc.
DW-2590
In Commercial Distribution

  • M269DW25901 ()
  • 10381780244844 ()

  • 2.756 in L x .031 in dia
DW-2590

  • Orthopaedic guidewire, reusable

Ti6® Internal Fixation System - 10381780244783

Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 digital fusion screws.
Ascension Orthopedics, Inc.
DS3010
In Commercial Distribution

  • M269DS30101 ()
  • 10381780244783 ()

  • 88 mm L x 2.67 mm dia
DS3010

  • Surgical screwdriver, reusable

First Choice® DRUJ System - 10381780243977

Integra® First Choice® DRUJ System The Integra First Choice DRUJ System tag is placed on the outer container.
Ascension Orthopedics, Inc.
CSA61002
In Commercial Distribution

  • M269CSA610021 ()
  • 10381780243977 ()

  • NA
CSA-610-02

  • Instrument tray, reusable

Cadence™ - 10381780240266

The Lamina Spreader is used to extend the Talar Cut Guide to tighten ligaments during preperation for talar resectioning procedure.
Ascension Orthopedics, Inc.
10203035
In Commercial Distribution

  • M268102030351 ()
  • 10381780240266 ()

  • 16.5mm L x 110mm W
10203035

  • Joint prosthesis implantation kit, reusable

Integra® First Choice® - 10381780236788

The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating congruency and joint articulation.
Ascension Orthopedics, Inc.
TRL600S65
In Commercial Distribution

  • M269TRL600S651 ()
  • 10381780236788 ()

  • 2.359 in L x .274 in stem dia
TRL-600-S65

  • Surgical implant template, reusable

Integra® First Choice® - 10381780236771

The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating congruency and joint articulation.
Ascension Orthopedics, Inc.
TRL600S55
In Commercial Distribution

  • M269TRL600S551 ()
  • 10381780236771 ()

  • 2.359 in L x .235 in stem dia
TRL-600-S55

  • Surgical implant template, reusable

Integra® First Choice® - 10381780236764

The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating congruency and joint articulation.
Ascension Orthopedics, Inc.
TRL600S45
In Commercial Distribution

  • M269TRL600S451 ()
  • 10381780236764 ()

  • 2.359 in L x .175 in stem dia
TRL-600-S45

  • Surgical implant template, reusable

TITAN™ - 10381780258612

The Fin-Lock Stepped Sizer is used to measure the size of the glenoid and mark the center of the glenoid.
Ascension Orthopedics, Inc.
SZR-0926-030-035
In Commercial Distribution

  • M269SZR09260300351 ()
  • 10381780258612 ()

  • Large + 5


  • Surgical implant template, reusable

TITAN™ - 10381780258575

The Fin-Lock Stepped Sizer is used to measure the size of the glenoid and mark the center of the glenoid.
Ascension Orthopedics, Inc.
SZR-0926-030-023
In Commercial Distribution

  • M269SZR09260300231 ()
  • 10381780258575 ()

  • Medium + 3


  • Surgical implant template, reusable

TITAN™ - 10381780258551

The Fin-Lock Stepped Sizer is used to measure the size of the glenoid and mark the center of the glenoid.
Ascension Orthopedics, Inc.
SZR-0926-030-015
In Commercial Distribution

  • M269SZR09260300151 ()
  • 10381780258551 ()

  • Small + 5


  • Surgical implant template, reusable
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