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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® - 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® - 10381780245971

Integra®Total Foot System The interfrag drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
LIGTFS18
In Commercial Distribution

  • M269LIGTFS181 ()
  • 10381780245971 ()

  • 1.3 in L x .91 in W
LIG-TFS-18

  • Surgical drill guide, reusable

Construct ™ - 10381780245940

Construct® Ankle Fusion Plate System The locking drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
LDG-5010-65
Not in Commercial Distribution

  • M269LDG5010651 ()
  • 10381780245940 ()

  • 2.166 in L x .201 in dia
LDG501065

  • Surgical drill guide, reusable

First Choice® DRUJ System - 10381780245773

Integra® First Choice® DRUJ System MUH Back Table Assy Pad The back table assembly plate is used to compare resected heads to the closest implant head size.
Ascension Orthopedics, Inc.
IMP60001
In Commercial Distribution

  • M269IMP600011 ()
  • 10381780245773 ()

  • 3.0 in dia x 1.0 in depth
IMP-600-01

  • Orthopaedic implant/instrument assembling device

Integra® - 10381780245742

Modular Radial Head Back Table Assembly Pad, MRH
Ascension Orthopedics, Inc.
IMP35001
In Commercial Distribution

  • M269IMP350011 ()
  • 10381780245742 ()

  • 3.0 in dia x 1.0 in depth
IMP-350-01

  • Orthopaedic implant/instrument assembling device

Integra® - 10381780245728

Surgical Instruments Implant Impactor
Ascension Orthopedics, Inc.
IMP30000
In Commercial Distribution

  • M269IMP300001 ()
  • 10381780245728 ()

  • 3.83 in L x 1.0 in W
IMP-300-00

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245582

Titan™ Total Shoulder System The head sizing gauge 48-52 is used to measure the resected head diameter and thickness.
Ascension Orthopedics, Inc.
HG0920041002
In Commercial Distribution

  • M269HSG09200410021 ()
  • 10381780245582 ()

  • 10.0 in L x 2.0 in W
HSG-0920-041-002

  • Surgical depth gauge, reusable

Titan™ - 10381780245575

Titan™ Total Shoulder System The head sizing gauge 38-46 is used to measure the resected head diameter and thickness.
Ascension Orthopedics, Inc.
HG0920041001
In Commercial Distribution

  • M269HSG09200410011 ()
  • 10381780245575 ()

  • 10.0 in L x 2.0 in W
HSG-0920-041-001

  • Surgical depth gauge, reusable

Construct ™ - 10381780245384

Construct® Ankle Fusion Plate System The right guide pin targeting base is used in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTB-1000-02
Not in Commercial Distribution

  • M269GTB1000021 ()
  • 10381780245384 ()

  • 3.18 in L x 2.73 in W
GTB100002

  • Orthopaedic guidewire, reusable

Construct ™ - 10381780245377

Construct® Ankle Fusion Plate System The left guide pin targeting base is used in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTB-1000-01
Not in Commercial Distribution

  • M269GTB1000011 ()
  • 10381780245377 ()

  • 3.18 in L x 2.73 in W
GTB100001

  • Orthopaedic guidewire, reusable
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