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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® 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™ 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™ 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™ 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® 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® 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® 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®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
Titan™ Total Shoulder System The head cutting depth gauge can be used to assess the cutting plane.
Ascension Orthopedics, Inc.
GU0920058001
In Commercial Distribution

  • M269GAU09200580011 ()
  • 10381780245278 ()

  • 5.25 in L
GAU-0920-058-001

  • Surgical depth gauge, reusable
Integra®Surgical Instruments The torque limiter is used during assembly and implantation of devices.
Ascension Orthopedics, Inc.
G207153
In Commercial Distribution

  • M269G2071531 ()
  • 10381780245261 ()

  • 4.52 in L
G207153

  • Surgical instrument torque limiter
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