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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® - 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® - 10381780248064

Integra® External Fixation System The box wrench combination h is used to tighten parts in the external fixation system.
Ascension Orthopedics, Inc.
12224502
In Commercial Distribution

  • M269122245021 ()
  • 10381780248064 ()

  • 178 mm L; 13.0 mm openings
12224502

  • 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

Integra® - 10381780248040

Integra® External Fixation System The tensioner alignment tool is used in conjunction with the external fixation system.
Ascension Orthopedics, Inc.
12224300
In Commercial Distribution

  • M269122243001 ()
  • 10381780248040 ()
12224300

  • External orthopaedic fixation system, reusable

Integra® - 10381780247876

Integra® Total Foot System The TX 8 non-cannulated driver with AO is used in conjunction with the Integra Total Foot system.
Ascension Orthopedics, Inc.
TXDTFS08
In Commercial Distribution

  • M269TXDTFS081 ()
  • 10381780247876 ()

  • 3.5 in L x .13 in dia tip
TXD-TFS-08

  • Surgical screwdriver, reusable

Construct ™ - 10381780247746

Construct® Ankle Fusion Plate System The TX 25 driver shaft with quick connect is used with the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
TSS-5010-01
In Commercial Distribution

  • M269TSS5010011 ()
  • 10381780247746 ()

  • 4.0 in L x .172 in dia tip
TSS501001

  • Surgical screwdriver, reusable
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