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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™ - 10381780245278

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® - 10381780245261

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

Ti6® Internal Fixation System - 10381780245056

Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 3.0 and 4.0mm screws.
Ascension Orthopedics, Inc.
FS2060
In Commercial Distribution

  • M269FS20601 ()
  • 10381780245056 ()

  • 3.516 in L
FS2060

  • Surgical drill guide, reusable

Ti6® Internal Fixation System - 10381780245049

Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 2.0 and 2.5mm screws.
Ascension Orthopedics, Inc.
FS2050
In Commercial Distribution

  • M269FS20501 ()
  • 10381780245049 ()

  • 3.074 in L
FS2050

  • Surgical drill guide, reusable

Integra®Ti6® - 10381780244950

Integra® Ti6® The screw removal tool is used in conjunction with the Integra Ti6 Screw system.
Ascension Orthopedics, Inc.
FS1040
In Commercial Distribution

  • M269FS10401 ()
  • 10381780244950 ()

  • 5.4 in L
FS1040

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra® Ti6® - 10381780244899

The titanium swivel driver handle is useful for inserting small screws.
Ascension Orthopedics, Inc.
FS1005
In Commercial Distribution

  • M269FS10051 ()
  • 10381780244899 ()

  • 4.08 in L
FS1005

  • Surgical instrument handle, non-torque-limiting

Ti6® Internal Fixation System - 10381780244769

Integra® Ti6® The ratchet handle is used in conjunction with the Digital Fusion screws.
Ascension Orthopedics, Inc.
DS1007
In Commercial Distribution

  • M269DS10071 ()
  • 10381780244769 ()

  • 5.92 in L
DS1007

  • Surgical instrument handle, non-torque-limiting

Construct ™ - 10381780244691

Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-5010-50
Not in Commercial Distribution

  • M269DRL5010501 ()
  • 10381780244691 ()

  • 6.72 in L
DRL501050

  • Cannulated surgical drill bit, single-use

Construct ™ - 10381780244684

Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-5010-32
Not in Commercial Distribution

  • M269DRL5010321 ()
  • 10381780244684 ()

  • 6.72 in L
DRL501032

  • Cannulated surgical drill bit, single-use

Construct ™ - 10381780244677

Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-1000-32
Not in Commercial Distribution

  • M269DRL1000321 ()
  • 10381780244677 ()

  • 10.21 in L
DRL100032

  • Cannulated surgical drill bit, single-use
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