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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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DigiFuse® Cannulated Intramedullary Fusion System - 10381780244424

Integra® DigiFuse® The ratchet handle is used in conjunction with the Integra DigiFuse system.
Ascension Orthopedics, Inc.
DF1500
In Commercial Distribution

  • M269DF15001 ()
  • 10381780244424 ()

  • 5.496 in L
DF1500

  • Surgical instrument handle, non-torque-limiting

Titan™ - 10381780244417

Titan™ Reverse Shoulder System The stem depth stop is used with the Titan Reverse Shoulder system.
Ascension Orthopedics, Inc.
DEP096006901
In Commercial Distribution

  • M269DEP0960069011 ()
  • 10381780244417 ()

  • .76 in W
DEP-0960-069-01

  • Surgical depth gauge, reusable

Titan™ - 10381780244394

Titan™ Reverse Shoulder System The double drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DDG096007701
In Commercial Distribution

  • M269DDG0960077011 ()
  • 10381780244394 ()

  • 6.00 in L
DDG-0960-077-01

  • Surgical drill guide, reusable

Construct ™ - 10381780244226

Construct® Ankle Fusion Plate System The Construct Ankle Fusion Plating System Countersink with AO QC is used to add space or clearance for the head of a screw being placed in the bone.
Ascension Orthopedics, Inc.
CSK-5010-01
Not in Commercial Distribution

  • M269CSK5010011 ()
  • 10381780244226 ()

  • 4.75 in L
CSK501001

  • Surgical screwdriver, reusable

Integra® - 10381780242178

Integra® Silicone PIP Starter Awl The Starter Awl is used to penetrate the articular surface and expose the canal of the metacarpal and phalangeal bone.
Ascension Orthopedics, Inc.
AWL-520-01
In Commercial Distribution

  • M269AWL520011 ()
  • 10381780242178 ()

  • 7.53 in L
AWL-520-01

  • Orthopaedic knife

Integra® - 10381780236269

The Stem Trial is used to verify proper implant placement and sizing.
Ascension Orthopedics, Inc.
TRL31004
In Commercial Distribution

  • M269TRL310041 ()
  • 10381780236269 ()

  • .289 in dia
TRL-310-04

  • Elbow radius prosthesis trial

Ascension® - 10381780236146

The Proximal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit in prepared cavities. The trial evaluates joint articulation and ligament tension.
Ascension Orthopedics, Inc.
TRL-101-50P
In Commercial Distribution

  • M269TRL10150P1 ()
  • 10381780236146 ()

  • 1.620 in L


  • Surgical implant template, reusable

Ascension® - 10381780236122

Ascension® MCP Proximal Metal Trial Size 40
Ascension Orthopedics, Inc.
TRL10140P
In Commercial Distribution

  • M269TRL10140P1 ()
  • 10381780236122 ()

  • 1.447 in L
TRL-101-40P

  • Surgical implant template, reusable

Ascension® - 10381780236108

Ascension® MCP Proximal Metal Trial Size 30
Ascension Orthopedics, Inc.
TRL10130P
In Commercial Distribution

  • M269TRL10130P1 ()
  • 10381780236108 ()

  • 1.275 in L
TRL-101-30P

  • Surgical implant template, reusable

Ascension® - 10381780236085

Ascension® MCP Proximal Metal Trial Size 20
Ascension Orthopedics, Inc.
TRL10120P
In Commercial Distribution

  • M269TRL10120P1 ()
  • 10381780236085 ()

  • 1.103 in L
TRL-101-20P

  • Surgical implant template, reusable
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