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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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Titan™ - 10381780245551

Titan™ Total Shoulder System Mini Glenoid Holder
Ascension Orthopedics, Inc.
HDR-0940-048-001
In Commercial Distribution

  • M269HDR09400480011 ()
  • 10381780245551 ()

  • 9.9 in L
HDR-0940-048-001

  • Orthopaedic implant/instrument assembling device

BioMotion® Cannulated 1st MPJ Hemi System - 10381780245513

Integra® BioMotion® Cannulated Hemi System The slide hammer is used to assist with implant placement into the bone.
Ascension Orthopedics, Inc.
HM 3010
In Commercial Distribution

  • M269HM30101 ()
  • 10381780245513 ()

  • 8.14 in L
HM 3010

  • Orthopaedic implant impactor, reusable

BioMotion® Cannulated 1st MPJ Hemi System - 10381780245506

Integra® BioMotion® Cannulated Hemi System BioMotion Slide Broach The BioMotion Slide Broach is used to prepare a cavity that provides a press fit for the implant.
Ascension Orthopedics, Inc.
HM 3005
In Commercial Distribution

  • M269HM30051 ()
  • 10381780245506 ()

  • 8.24 in L
HM 3005

  • Orthopaedic broach

Titan™ - 10381780245490

Titan™ Total Shoulder System The humeral depth stop is used for precise measurement.
Ascension Orthopedics, Inc.
HS0920069001
In Commercial Distribution

  • M269HDS09200690011 ()
  • 10381780245490 ()

  • .76 in W
HDS-0920-069-001

  • Surgical depth gauge, reusable

Titan™ - 10381780245452

Titan™ Total Shoulder System The anti-rotation peg holder is used to assist with the placement of the anti-rotation peg in the Titan Total Shoulder system.
Ascension Orthopedics, Inc.
HL0920075001
In Commercial Distribution

  • M269HDL09200750011 ()
  • 10381780245452 ()

  • 8.5 in L
HDL-0920-075-001

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780245445

Titan™ Total Shoulder System The stem trial handle is used to assist with the placement of the stem trial.
Ascension Orthopedics, Inc.
HL0920043001
In Commercial Distribution

  • M269HDL09200430011 ()
  • 10381780245445 ()

  • 6.35 in L
HDL-0920-043-001

  • Surgical instrument handle, non-torque-limiting

Construct ™ - 10381780245407

Construct® Ankle Fusion Plate System The guide pin targeting sleeve is attached to the guide pin targeting base in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTS-1000-01
Not in Commercial Distribution

  • M269GTS1000011 ()
  • 10381780245407 ()

  • 3.0 in L
GTS100001

  • Surgical drill guide, reusable

Construct® - 10381780245391

Construct® Ankle Fusion Plate System The targeting base knob is used in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTB-1000-03
Not in Commercial Distribution

  • M269GTB1000031 ()
  • 10381780245391 ()

  • 1.935 in L
GTB-1000-03

  • Orthopaedic implant/instrument assembling device

Construct® - 10381780245346

Construct® Ankle Fusion Plate System The Smith Peterson straight osteotome is used for cutting bone.
Ascension Orthopedics, Inc.
gS 52.5520
Not in Commercial Distribution

  • M269GS5255201 ()
  • 10381780245346 ()

  • .75 in W
gS 52.5520

  • Orthopaedic osteotome

Integra® - 10381780245308

Integra®Surgical Instruments The Guide Pin is used in conjunction with the cup and cone reamers.
Ascension Orthopedics, Inc.
GDW-895-00
In Commercial Distribution

  • M269GDW895001 ()
  • 10381780245308 ()

  • 6.0 in L
GDW-895-00

  • Orthopaedic guidewire, reusable
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