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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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Biomet Orthopedics, LLC
35-463005
In Commercial Distribution

  • 70880304359955 ()
  • 00880304359956 ()

  • DIA. 5/64 IN.(2.0MM), LENGTH: 5 IN.
35-463005

  • Fluted surgical drill bit, reusable
No Description
Biomet Orthopedics, LLC
35-463004
In Commercial Distribution

  • 00880304359949 ()

  • DIA. 1/16 IN.(1.6MM), LENGTH: 5 IN.
35-463004

  • Fluted surgical drill bit, reusable
The Fin-Lock Punch is used to impact the bone for proper fit of the glenoid. It can also be used to further pressurize the cement.
Ascension Orthopedics, Inc.
PN-0926-001
In Commercial Distribution

  • M269PN09260011 ()
  • 10381780258353 ()

  • 8.0 in L x 1.5 in end diameter


  • Bone cutter
Integra® Total Foot System The TX 8 non-cannulated driver with AO is used in conjunction with the Integra Total Foot system.
Ascension Orthopedics, Inc.
TXDTFS08
In Commercial Distribution

  • M269TXDTFS081 ()
  • 10381780247876 ()

  • 3.5 in L x .13 in dia tip
TXD-TFS-08

  • Surgical screwdriver, reusable
Construct® Ankle Fusion Plate System The TX 25 driver shaft with quick connect is used with the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
TSS-5010-01
In Commercial Distribution

  • M269TSS5010011 ()
  • 10381780247746 ()

  • 4.0 in L x .172 in dia tip
TSS501001

  • Surgical screwdriver, reusable
Titan™ Total Shoulder System The taper adaptor shaft is used to place the taper adaptor onto the body trial.
Ascension Orthopedics, Inc.
SR0920066001
In Commercial Distribution

  • M269SCR09200660011 ()
  • 10381780247340 ()

  • 5.5 in L x .176 in tip dia
SCR-0920-066-001

  • Bone tap, reusable
Titan™ Total Shoulder System The cemented long stem reamer is used to compress and/or remove bone to create a cavity of proper shape and size.
Ascension Orthopedics, Inc.
R95002514165
In Commercial Distribution

  • M269RMR0950025141651 ()
  • 10381780247258 ()

  • .552 in dia x 6.5 in flute L
RMR-0950-025-14165

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System The cemented long stem reamer is used to compress and/or remove bone to create a cavity of proper shape and size.
Ascension Orthopedics, Inc.
R95002514125
In Commercial Distribution

  • M269RMR0950025141251 ()
  • 10381780247241 ()

  • .552 in dia x 4.92 in flute L
RMR-0950-025-14125

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System The cemented long stem reamer is used to compress and/or remove bone to create a cavity of proper shape and size.
Ascension Orthopedics, Inc.
R95002512165
In Commercial Distribution

  • M269RMR0950025121651 ()
  • 10381780247234 ()

  • .473 in dia x 6.5 in flute L
RMR-0950-025-12165

  • Bone-resection orthopaedic reamer, reusable
Titan™ Total Shoulder System The cemented long stem reamer is used to compress and/or remove bone to create a cavity of proper shape and size.
Ascension Orthopedics, Inc.
R95002512125
In Commercial Distribution

  • M269RMR0950025121251 ()
  • 10381780247227 ()

  • .473 in dia x 4.92 in flute L
RMR-0950-025-12125

  • Bone-resection orthopaedic reamer, reusable
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