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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® - 10381780247944

Integra® Titanium Bone Wedge System The LCL Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-1006-03
Not in Commercial Distribution

  • M269CSA1006031 ()
  • 10381780247944 ()

  • 6.584 in L x 5.215 in W
CSA100603

  • Instrument tray, reusable

Titan™ - 10381780247555

Titan™ Total Shoulder System The taper disassembly tool is used in the total shoulder system.
Ascension Orthopedics, Inc.
TT0920044001
In Commercial Distribution

  • M269TDT09200440011 ()
  • 10381780247555 ()

  • 4.0 in L x 1.0 in H
TDT-0920-044-001

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780247500

Titan™ Total Shoulder System The stand is used as a base during head impaction.
Ascension Orthopedics, Inc.
SD0920071001
In Commercial Distribution

  • M269STD09200710011 ()
  • 10381780247500 ()

  • 5.16 in L x 4.26 in H
STD-0920-071-001

  • Surgical implant/trial-implant/sizer holder, reusable

Integra® - 10381780246619

Integra®Surgical Instruments The fixation pin helps with stabilization.
Ascension Orthopedics, Inc.
PN0920051001
In Commercial Distribution

  • M269PIN09200510011 ()
  • 10381780246619 ()

  • 4.0 in L x .094 in dia
PIN-0920-051-001

  • Orthopaedic guidewire, reusable

Titan™ - 10381780246596

Titan™ Reverse Shoulder System The anti-rotation baseplate peg is used to maintain baseplate orientation.
Ascension Orthopedics, Inc.
PEG096007301
In Commercial Distribution

  • M269PEG0960073011 ()
  • 10381780246596 ()

  • .79 in L x .307 in dia
PEG-0960-073-01

  • Orthopaedic implant aiming arm

Integra® - 10381780246343

Integra®Surgical Instruments The ratchet t-handle is provided with quick connect.
Ascension Orthopedics, Inc.
NR135004J004
In Commercial Distribution

  • M269NR135004J0041 ()
  • 10381780246343 ()

  • 4.5 in L x 3.88 in W
NR135004-J-004

  • Surgical instrument handle, non-torque-limiting

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
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