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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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PROBE, STAINLESS STEEL
ARTHREX, INC.
AR-10020
In Commercial Distribution

  • 00888867002371 ()
AR-10020

  • Soft-tissue surgical hook, reusable
PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
ARTHREX, INC.
AR-10010
In Commercial Distribution

  • 00888867002364 ()
AR-10010

  • Soft-tissue surgical hook, reusable
PROBE, HOOK 5.4MM TIP W/5MM MARKINGS
ARTHREX, INC.
AR-10000
In Commercial Distribution

  • 00888867002357 ()
AR-10000

  • Soft-tissue surgical hook, reusable
The SmartBase Central Pillar is a component of the SmartBase that holds the guide pin to set the Intelligent Reusable Instrument (IRI) according to a patient-specific preoperative plan. The SmartBase Central Pillar is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
K
Not in Commercial Distribution

  • 00811813020303 ()

  • Outer Diameter: .188 Inch
  • Lumen/Inner Diameter: .132 Inch
  • Length: 38.1 Millimeter
0006-0033

  • Orthopaedic bone pin container
  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The SmartBase Core is the base component of the SmartBase Assembly, which is used to set the Intelligent Reusable Instrument (IRI). The SmartBase Assembly is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
J
Not in Commercial Distribution

  • 00811813020297 ()

  • Lumen/Inner Diameter: 4.9 Millimeter
  • Height: 42 Millimeter
0006-0032

  • Orthopaedic bone pin container
  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at the time of surgery. This bone model is a 1-to-1 representation of a specific patient's bony anatomy. The SmartBone is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
A
Not in Commercial Distribution

  • 00811813020235 ()

  • Patient-specific
0006-0007-UPI

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The Glenoid IRI Leg (25mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (25mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020198 ()

  • Length: 25 Millimeter
0006-0005-25

  • Orthopaedic prosthesis implantation positioning instrument, reusable
  • Orthopaedic implant/instrument assembling device
The Glenoid IRI Leg (24mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (24mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020181 ()

  • Length: 24 Millimeter
0006-0005-24

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (23mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (23mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020174 ()

  • Length: 23 Millimeter
0006-0005-23

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (22mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (22mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020167 ()
0006-0005-22

  • Orthopaedic prosthesis implantation positioning instrument, reusable
  • Orthopaedic implant/instrument assembling device
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