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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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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

TruArch® Subtalar Implant System - 10381780247531

Integra® TruArch® The TruArch removal driver is used to remove the implant.
Ascension Orthopedics, Inc.
TA-3115
In Commercial Distribution

  • M269TA31151 ()
  • 10381780247531 ()

  • 165.1 mm L x 5 mm dia
TA-3115

  • Surgical screwdriver, reusable

Titan™ - 10381780247302

Titan™ Total Shoulder System The handle is used with the head cutting template.
Ascension Orthopedics, Inc.
ROD-0923-040-001
In Commercial Distribution

  • M269ROD09230400011 ()
  • 10381780247302 ()

  • 6.23 in L x .19 in dia
ROD-0923-040-001

  • Surgical instrument handle, non-torque-limiting

Titan™ - 10381780247296

Titan™ Total Shoulder System The handle is used with the head cutting template.
Ascension Orthopedics, Inc.
RD0920040002
In Commercial Distribution

  • M269ROD09200400021 ()
  • 10381780247296 ()

  • 6.23 in L x .19 in dia
ROD-0920-040-002

  • Surgical instrument handle, non-torque-limiting

MemoFix® Super Elastic Nitinol Staple System - 10381780246114

Integra® MemoFix® Staple System The MemoFix pin is used for temporary fixation.
Ascension Orthopedics, Inc.
MS-2660
In Commercial Distribution

  • M269MS26601 ()
  • 10381780246114 ()

  • 71.12 mm L x 2.6 mm dia
MS-2660

  • Orthopaedic guidewire, reusable

MemoFix® Super Elastic Nitinol Staple System - 10381780246107

Integra® MemoFix® Staple System The MemoFix pin is used for temporary fixation.
Ascension Orthopedics, Inc.
MS-2650
In Commercial Distribution

  • M269MS26501 ()
  • 10381780246107 ()

  • 71.12 mm L x 1.9 mm dia
MS-2650

  • Orthopaedic guidewire, reusable

MemoFix® Super Elastic Nitinol Staple System - 10381780246091

Integra® MemoFix® Staple System The MemoFix pin is used for temporary fixation.
Ascension Orthopedics, Inc.
MS-2640
In Commercial Distribution

  • M269MS26401 ()
  • 10381780246091 ()

  • 71.12 mm L x 1.6 mm dia
MS-2640

  • Orthopaedic guidewire, reusable

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
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