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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 The BioMotion hemi rasp is a coarse file to remove bone.
Ascension Orthopedics, Inc.
HM 3030
In Commercial Distribution

  • M269HM30301 ()
  • 10381780245520 ()

  • 92.6 mm L x 21 mm dia cutter
HM 3030

  • Bone file/rasp, manual, reusable
Integra® Ti6® The drill bit is a cutting tool used to create 4.0 mm cylindrical holes.
Ascension Orthopedics, Inc.
FS2004
In Commercial Distribution

  • M269FS20041 ()
  • 10381780244998 ()

  • 100 mm L x 2.7 mm dia tip
FS2004

  • Cannulated surgical drill bit, single-use
Integra® DigiFuse® The DigiFuse Instrument Sterilization Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
DT-4500
In Commercial Distribution

  • M269DT45001 ()
  • 10381780244813 ()

  • 8.0 in L x 6.0 in W x 1.46 in H
DT-4500

  • Instrument tray, reusable
Integra® DigiFuse® The DigiFuse Instrument Sterilization Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
DT-3500
Not in Commercial Distribution

  • M269DT35001 ()
  • 10381780244790 ()

  • 8.0 in L x 6.0 in W x 1.46 in H
DT-3500

  • Instrument tray, reusable
CAPTURE™ High Torque Screw System The cannulated tap is a tool used to produce a threaded hole.
Ascension Orthopedics, Inc.
CNT-5000-503-070
In Commercial Distribution

  • M269CNT50005030701 ()
  • 10381780242888 ()

  • 259 mm L x 5.18 mm dia
NT5000503070

  • Cannulated surgical drill bit, single-use
Construct® Ankle Fusion Plate System The compression drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
CDG-5010-01
Not in Commercial Distribution

  • M269CDG5010011 ()
  • 10381780242802 ()

  • 5.46 in L x 2.160 in W
CDG501001

  • Surgical drill guide, reusable
CAPTURE™ Cannulated Screw System The ratchet handle is used in conjunction with the Capture Cannulated Screw System.
Ascension Orthopedics, Inc.
AI-1006
In Commercial Distribution

  • M269AI10061 ()
  • 10381780241805 ()

  • 5.9 in L
AI1006

  • Surgical instrument handle, non-torque-limiting
The humeral body inserter/extractor is used to insert the implant into its place, as well as extract.
Ascension Orthopedics, Inc.
INS096004801
In Commercial Distribution

  • M269INS0960048011 ()
  • 10381780237112 ()

  • 8.36 in L
INS-0960-048-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
The Definitive Stem Reverse Shoulder Body Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
DTL096008STD
In Commercial Distribution

  • M269DTL096008STD1 ()
  • 10381780235439 ()

  • Standard
DTL-096-008STD

  • Humeral stem prosthesis trial, reusable
The Definitive Stem Reverse Shoulder Body Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
DTL096008SML
In Commercial Distribution

  • M269DTL096008SML1 ()
  • 10381780235422 ()

  • Small
DTL-0960-08SML

  • Humeral stem prosthesis trial, reusable
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