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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® PyroSphere® - 10381780236467

Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43520
In Commercial Distribution

  • M269TRL435201 ()
  • 10381780236467 ()

  • Size 20; .457 in dia
TRL-435-20

  • Carpometacarpal interpositional spacer prosthesis trial

Integra® PyroSphere® - 10381780236450

Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43510
In Commercial Distribution

  • M269TRL435101 ()
  • 10381780236450 ()

  • Size 10; .403 in dia
TRL-435-10

  • Carpometacarpal interpositional spacer prosthesis trial

Cadence™ - 10381780240143

Rod Connector is a part of the Tibial Alignment guide, and is used to connect the Tibial Rod to the Proximal Translation Block for proper positioning to the center of the patients distal tibial metaphysis.
Ascension Orthopedics, Inc.
10203005
In Commercial Distribution

  • M268102030051 ()
  • 10381780240143 ()

  • 1.7 in Lx .709in diameter
10203005

  • Joint prosthesis implantation kit, reusable

Integra® - 10381780237310

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9004820
In Commercial Distribution

  • M269SZR90048201 ()
  • 10381780237310 ()

  • Size 48-20; 1.89 in dia
SZR-900-48-20

  • Surgical implant template, reusable

Integra® - 10381780237303

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9004817
In Commercial Distribution

  • M269SZR90048171 ()
  • 10381780237303 ()

  • Size 48-18; 1.89 in dia
SZR-900-48-17

  • Surgical implant template, reusable

Integra® - 10381780237297

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9004418
In Commercial Distribution

  • M269SZR90044181 ()
  • 10381780237297 ()

  • Size 44-18; 1.732 in dia
SZR-900-44-18

  • Surgical implant template, reusable

Integra® - 10381780237280

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9004415
In Commercial Distribution

  • M269SZR90044151 ()
  • 10381780237280 ()

  • Size 44-15; 1.732 in dia
SZR-900-44-15

  • Surgical implant template, reusable

Integra® - 10381780237273

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9004016
In Commercial Distribution

  • M269SZR90040161 ()
  • 10381780237273 ()

  • Size 40-16; 1.575 in dia
SZR-900-40-16

  • Surgical implant template, 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
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