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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® - 10381780248149

Integra® External Fixation System The wire tensioner is used to apply tension to the wires after they are run through the bone and attached to the ring.
Ascension Orthopedics, Inc.
12225300
In Commercial Distribution

  • M269122253001 ()
  • 10381780248149 ()

  • .004 in opening
12225300

  • External orthopaedic fixation system, reusable

Integra® - 10381780248132

Integra® External Fixation System The provisional midfoot support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225060
In Commercial Distribution

  • M269122250601 ()
  • 10381780248132 ()

  • 5.702 in L
12225060

  • External orthopaedic fixation system, reusable

Integra® - 10381780248125

Integra® External Fixation System The provisional heel support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225050
In Commercial Distribution

  • M269122250501 ()
  • 10381780248125 ()

  • 6.238 in L
12225050

  • External orthopaedic fixation system, reusable

Integra® - 10381780248118

Integra® External Fixation System The provisional calf support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225040
In Commercial Distribution

  • M269122250401 ()
  • 10381780248118 ()

  • 6.883 in L
12225040

  • External orthopaedic fixation system, reusable

Integra® - 10381780248101

Integra® External Fixation System The wire cutter is a tool used to cut wire with the External Fixation System.
Ascension Orthopedics, Inc.
12224508
In Commercial Distribution

  • M269122245081 ()
  • 10381780248101 ()

  • 222.7 mm L
12224508

  • External orthopaedic fixation system, reusable

Integra® - 10381780248088

Integra® External Fixation System The pivoting socket wrench is used to tighten nuts and other parts in the external fixation system.
Ascension Orthopedics, Inc.
12224506
In Commercial Distribution

  • M269122245061 ()
  • 10381780248088 ()

  • 157.8 mm L; 10.03 mm opening
12224506

  • External orthopaedic fixation system, reusable

Integra® - 10381780248071

Integra® External Fixation System The universal bolt tubular wrench is used to tighten bolts and other parts in the external fixation system.
Ascension Orthopedics, Inc.
12224504
In Commercial Distribution

  • M269122245041 ()
  • 10381780248071 ()

  • 168.96 mm L; 10.1 mm opening
12224504

  • External orthopaedic fixation system, reusable

Integra® - 10381780248057

Integra® External Fixation System The box wrench combination h is used to tighten parts in the external fixation system.
Ascension Orthopedics, Inc.
12224501
In Commercial Distribution

  • M269122245011 ()
  • 10381780248057 ()

  • 145 mm L; 10.0 mm openings
12224501

  • External orthopaedic fixation system, reusable

Ti6® Internal Fixation System - 10381780247562

Integra® Ti6® The Ti6 Base Instrument Set contains instruments used to aid in the implantation of the Ti6 Screws.
Ascension Orthopedics, Inc.
TI6INSTP
Not in Commercial Distribution

  • M269TI6INSTP1 ()
  • 10381780247562 ()

  • 6.97in L x 5.80in W x 1.50in H
TI6INSTP

  • Instrument tray, reusable

TruArch® Subtalar Implant System - 10381780247531

Integra® TruArch® The TruArch removal driver is used to remove the implant.
Ascension Orthopedics, Inc.
TA-3115
In Commercial Distribution

  • M269TA31151 ()
  • 10381780247531 ()

  • 165.1 mm L x 5 mm dia
TA-3115

  • Surgical screwdriver, reusable
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