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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™ - 10381780247128

Titan™ Total Shoulder System TSS Glenoid Five Flute Reamer Sz. S The glenoid fluted reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920059001
In Commercial Distribution

  • M269RMR09200590011 ()
  • 10381780247128 ()

  • Size S; 1.0 in L x 1.35 in dia
RMR-0920-059-001

  • Bone-resection orthopaedic reamer, reusable

Titan™ - 10381780247111

Titan™ Total Shoulder System TSS Glenoid Five Flute Reamer Sz. XS The glenoid fluted reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
RR0920059000
In Commercial Distribution

  • M269RMR09200590001 ()
  • 10381780247111 ()

  • Size XS; 1.0 in L x 1.25 in dia
RMR-0920-059-000

  • Bone-resection orthopaedic reamer, reusable

Integra® Jarit® - 10381780216209

Integra® Jarit® Grossman Areola Marker, 4 Sizes, 40mm, 44mm, 48mm, 52mm, Aluminum
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
P454
In Commercial Distribution

  • M274P4541 ()
  • 10381780216209 ()
P454

  • Surgical implant template, reusable

TiWedge™ - 10381780237679

The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Ascension Orthopedics, Inc.
TRL-1006-C05
Not in Commercial Distribution

  • M269TRL1006C051 ()
  • 10381780237679 ()

  • 70mm L handle ; 20.0 mm L x 5.5 mm H Trial Wedge


  • Surgical implant template, reusable

TiWedge™ - 10381780237655

The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Ascension Orthopedics, Inc.
TRL-1006-C03
Not in Commercial Distribution

  • M269TRL1006C031 ()
  • 10381780237655 ()

  • 70mm L handle ; 16.0 mm L x 6.5 mm H Trial Wedge


  • Surgical implant template, reusable

TiWedge™ - 10381780237648

The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Ascension Orthopedics, Inc.
TRL-1006-C02
Not in Commercial Distribution

  • M269TRL1006C021 ()
  • 10381780237648 ()

  • 70mm L handle ; 16.0 mm L x 5.5 mm H Tial Wedge


  • Surgical implant template, reusable

TiWedge™ - 10381780237631

The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Ascension Orthopedics, Inc.
TRL-1006-C01
Not in Commercial Distribution

  • M269TRL1006C011 ()
  • 10381780237631 ()

  • 70mm L handle ; 16.0 mm L x 4.5 mm H Trial Wedge


  • Surgical implant template, reusable

TiWedge™ - 10381780237624

The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Ascension Orthopedics, Inc.
TRL-1006-L09
Not in Commercial Distribution

  • M269TRL1006L091 ()
  • 10381780237624 ()

  • 70mm L handle ; 22.0 mm L x 20.0 mm W x 12.0 mm H Trial Wedge


  • Surgical implant template, reusable

TiWedge™ - 10381780237617

The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Ascension Orthopedics, Inc.
TRL-1006-L08
Not in Commercial Distribution

  • M269TRL1006L081 ()
  • 10381780237617 ()

  • 70mm L handle ; 22.0 mm L x 20.0 mm W x 10.0 mm H Trial Wedge


  • Surgical implant template, reusable

TiWedge™ - 10381780237600

The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Ascension Orthopedics, Inc.
TRL-1006-L07
Not in Commercial Distribution

  • M269TRL1006L071 ()
  • 10381780237600 ()

  • 70mm L handle ; 22.0 mm L x 20.0 mm W x 8.0 mm H


  • Surgical implant template, reusable
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