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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® - 10381780237457

PyroCarbon PIP Total Joint PIP Distal Template
Ascension Orthopedics, Inc.
TMP20001
In Commercial Distribution

  • M269TMP200011 ()
  • 10381780237457 ()

  • 2.378 in L x 2.418 in W
TMP-200-01

  • Surgical implant template, reusable

Movement® - 10381780237150

The Movement Great Toe proximal phalanx implant sizer allows for clear visualization of the implant size.
Ascension Orthopedics, Inc.
PIS89000
In Commercial Distribution

  • M269PIS890001 ()
  • 10381780237150 ()

  • 3.907 in L x 3.865 in W


  • Surgical implant template, reusable

Integra® PyroSphere® - 10381780237044

PCS Implant Extractor used to remove implants.
Ascension Orthopedics, Inc.
EXT43001
In Commercial Distribution

  • M269EXT430011 ()
  • 10381780237044 ()

  • 7.9 in L x 3.1 in W
EXT-430-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra® - 10381780237037

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005621
In Commercial Distribution

  • M269TRL90056211 ()
  • 10381780237037 ()

  • 2.245 in dia x .825 in H
TRL-900-56/21

  • Humeral head prosthesis trial, reusable

Integra® - 10381780237020

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005221
In Commercial Distribution

  • M269TRL90052211 ()
  • 10381780237020 ()

  • 2.047 in dia x .825 in H
TRL-900-52/21

  • Humeral head prosthesis trial, reusable

Integra® - 10381780237013

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005218
In Commercial Distribution

  • M269TRL90052181 ()
  • 10381780237013 ()

  • 2.047 in dia x .707 in H
TRL-900-52/18

  • Humeral head prosthesis trial, reusable

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

Integra® First Choice® - 10381780236733

The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluating congurency and joint articulation.
Ascension Orthopedics, Inc.
TRL600H190
In Commercial Distribution

  • M269TRL600H1901 ()
  • 10381780236733 ()

  • .748 in dia x .433 in H
TRL-600-H190

  • Surgical implant template, reusable

Integra® First Choice® - 10381780236719

The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluating congurency and joint articulation.
Ascension Orthopedics, Inc.
TRL600H160
In Commercial Distribution

  • M269TRL600H1601 ()
  • 10381780236719 ()

  • .630 in dia x .433 in H
TRL-600-H160

  • Surgical implant template, reusable

Integra® - 10381780242154

Surgical Instruments Starter Awl
Ascension Orthopedics, Inc.
AWL10001
In Commercial Distribution

  • M269AWL100011 ()
  • 10381780242154 ()

  • 3.26 in L x .118 in dia
AWL-100-01

  • Orthopaedic knife
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