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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® - 10381780246022

Integra® Modular Radial Head The planar is used with the modular radial head.
Ascension Orthopedics, Inc.
MRHPLN00
In Commercial Distribution

  • M269MRHPLN001 ()
  • 10381780246022 ()

  • 2.36 in W handle; .683in diameter cutting edge
MRH-PLN-00

  • Bone-resection orthopaedic reamer, reusable

Integra® - 10381780245988

Integra®Surgical Instruments The slotted mallet is used to hit or chisel bone.
Ascension Orthopedics, Inc.
MAL092008501
In Commercial Distribution

  • M269MAL0920085011 ()
  • 10381780245988 ()

  • 8.7 in L x 2.5 in W
MAL-0920-085-01

  • Orthopaedic implant impactor, reusable

Integra®Ti6® - 10381780245919

Integra® Ti6® The Ti6 TC-Series Threaded K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
KW1104
In Commercial Distribution

  • M269KW11041 ()
  • 10381780245919 ()

  • 4.72in L x 1.10in Diameter
KW1104

  • Orthopaedic guidewire, reusable

Integra® - 10381780244882

Integra® Total Foot System The Forefoot Distraction Gauge is used to assess size.
Ascension Orthopedics, Inc.
FDGTFS01
In Commercial Distribution

  • M269FDGTFS011 ()
  • 10381780244882 ()

  • 50 mm L
FDG-TFS-01

  • Surgical depth gauge, reusable

Ascension® - 10381780243403

Integra®Surgical Instruments The Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA10005
In Commercial Distribution

  • M269CSA100051 ()
  • 10381780243403 ()
CSA-100-05

  • Instrument tray, reusable

Titan™ - 10381780245490

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

Integra®Ti6® - 10381780245209

Integra® Ti6® The cannulated relief drill is used with the TH-series screws.
Ascension Orthopedics, Inc.
FS4030
In Commercial Distribution

  • M269FS40301 ()
  • 10381780245209 ()

  • 2.75in L x drill bit .47in L x .09in diamter
FS4030

  • Cannulated surgical drill bit, single-use

TITAN™ - 10381780258315

The guidewire is used as a guide for placement or insertion of a device.
Ascension Orthopedics, Inc.
GDW-0926-001
In Commercial Distribution

  • M269GDW09260011 ()
  • 10381780258315 ()

  • 8.5 in L x .11 in dia


  • Orthopaedic guidewire, reusable

TITAN™ - 10381780258193

The Fin-Lock Instrument Tray Reamer Caddy is a smaller container wherein devices are placed.
Ascension Orthopedics, Inc.
CSA-0926-05
In Commercial Distribution

  • M269CSA0926051 ()
  • 10381780258193 ()

  • 9.81 in L x 2.75 in W x 1.55 in H


  • Instrument tray, reusable

TITAN™ - 10381780258179

The Fin-Lock Instrument Tray Drill Caddy is a smaller container wherein devices are placed.
Ascension Orthopedics, Inc.
CSA-0926-03
In Commercial Distribution

  • M269CSA0926031 ()
  • 10381780258179 ()

  • 9.25 in L x 3.10 in W x 1.44 in H


  • Instrument tray, reusable
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