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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® - 10381780245988

Integra®Surgical Instruments The slotted mallet is used to hit or chisel bone.
Ascension Orthopedics, Inc.
MAL092008501
In Commercial Distribution

  • M269MAL0920085011 ()
  • 10381780245988 ()

  • 8.7 in L x 2.5 in W
MAL-0920-085-01

  • Orthopaedic implant impactor, reusable

Integra®Ti6® - 10381780245919

Integra® Ti6® The Ti6 TC-Series Threaded K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
KW1104
In Commercial Distribution

  • M269KW11041 ()
  • 10381780245919 ()

  • 4.72in L x 1.10in Diameter
KW1104

  • Orthopaedic guidewire, reusable

Integra® - 10381780244882

Integra® Total Foot System The Forefoot Distraction Gauge is used to assess size.
Ascension Orthopedics, Inc.
FDGTFS01
In Commercial Distribution

  • M269FDGTFS011 ()
  • 10381780244882 ()

  • 50 mm L
FDG-TFS-01

  • Surgical depth gauge, reusable

Ascension® - 10381780243403

Integra®Surgical Instruments The Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA10005
In Commercial Distribution

  • M269CSA100051 ()
  • 10381780243403 ()
CSA-100-05

  • Instrument tray, reusable

Movement® - 10381780236931

The Metatarsal Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89040MT
In Commercial Distribution

  • M269TRL89040MT1 ()
  • 10381780236931 ()

  • Size 40; .749 in L


  • Surgical implant template, reusable

Movement® - 10381780236900

The Metatarsal Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89030MT
In Commercial Distribution

  • M269TRL89030MT1 ()
  • 10381780236900 ()

  • Size 30; .709 in L


  • Surgical implant template, reusable

Movement® - 10381780236870

The Metatarsal Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89020MT
In Commercial Distribution

  • M269TRL89020MT1 ()
  • 10381780236870 ()

  • Size 20; .669 in L


  • Surgical implant template, reusable

Movement® - 10381780236849

The Metatarsal Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89010MT
In Commercial Distribution

  • M269TRL89010MT1 ()
  • 10381780236849 ()

  • Size 10; .629 in L


  • Surgical implant template, reusable

Integra® - 10381780236832

The Lunate Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL71505T
In Commercial Distribution

  • M269TRL71505T1 ()
  • 10381780236832 ()

  • .7874 in L x .5787 in H
TRL-715-05T

  • Carpometacarpal interpositional spacer prosthesis trial

Integra® - 10381780236825

The Lunate Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL71504T
In Commercial Distribution

  • M269TRL71504T1 ()
  • 10381780236825 ()

  • .7205 in L x .5433 in H
TRL-715-04T

  • Carpometacarpal interpositional spacer prosthesis trial
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