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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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Glenoid IRIS Surgical Tray - 00811813020020

The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that contains all of the Arthrex Glenoid IRIS devices. All of the Arthrex Glenoid (IRIS) devices are indicated for steam sterilization in this surgical tray. The following are contained in the tray: Glenoid IRI Barrel (DI: 00811813020013) [Q.1] Glenoid IRI Handle (DI: 00811813020006) [Q.1] Glenoid IRI Collet/Cap (DI: 00811813020037) [Q.1] Glenoid IRI Leg - 10mm (DI: 00811813020044) [Q.1] Glenoid IRI Leg - 12mm (DI: 00811813020068) [Q.1] Glenoid IRI Leg - 11mm (DI: 00811813020051) [Q.1] Glenoid IRI Leg - 13mm (DI: 00811813020075) [Q.1] Glenoid IRI Leg - 14mm (DI: 00811813020082) [Q.1] Glenoid IRI Leg - 15mm (DI: 00811813020099) [Q.2] Glenoid IRI Leg - 16mm (DI: 00811813020105) [Q.2] Glenoid IRI Leg - 17mm (DI: 00811813020112) [Q.2] Glenoid IRI Leg - 18mm (DI: 00811813020129) [Q.2] Glenoid IRI Leg - 19mm (DI: 00811813020136) [Q.2] Glenoid IRI Leg - 20mm (DI: 00811813020143) [Q.2] Glenoid IRI Leg - 21mm (DI: 00811813020150) [Q.2] Glenoid IRI Leg - 22mm (DI: 00811813020167) [Q.2] Glenoid IRI Leg - 23mm (DI: 00811813020174) [Q.2] Glenoid IRI Leg - 24mm (DI: 00811813020181) [Q.2] Glenoid IRI Leg - 25mm (DI: 00811813020198) [Q.2] SmartBase Core (DI: 00811813020297) [Q.1] SmartBase Center Pillar (DI: 00811813020303) [Q.1] SmartBase Ruler (DI: 00811813020280) [Q.5] SmartBase Screws (DI: 00811813020334) [Q.5] SmartBone Mount (DI: 00811813020204) [Q.1] Optional: SmartBone (DI: 00811813020235) [Q.1]
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
E
Not in Commercial Distribution

  • 00811813020020 ()

  • Width: 8.537 Inch
  • Length: 20 Inch
  • Height: 3.9 Inch
0006-0011

  • Instrument tray, reusable

SmartBase Central Pillar - 00811813020303

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

SmartBase Core - 00811813020297

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

SmartBone - 00811813020235

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

Glenoid IRI Leg (25 mm) - 00811813020198

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

Arthrex® - 00888867554306

One-step dilator, 10.0mm x 185mm
ARTHREX, INC.
AR-S3025-100-185
In Commercial Distribution

  • 00888867554306 ()
AR-S3025-100-185

  • Endoscopic-access dilator, reusable

Arthrex® - 00888867554290

One-step dilator, 7.0mm x 265mm
ARTHREX, INC.
AR-S3025-070-265
In Commercial Distribution

  • 00888867554290 ()
AR-S3025-070-265

  • Endoscopic-access dilator, reusable

Arthrex® - 00888867554283

One-step dilator, 7.0mm x 225mm
ARTHREX, INC.
AR-S3025-070-225
In Commercial Distribution

  • 00888867554283 ()
AR-S3025-070-225

  • Endoscopic-access dilator, reusable

Arthrex® - 00888867554276

One-step dilator, 6.3mm x 265mm
ARTHREX, INC.
AR-S3025-063-265
In Commercial Distribution

  • 00888867554276 ()
AR-S3025-063-265

  • Endoscopic-access dilator, reusable

Arthrex® - 00888867554269

One-step dilator, 6.3mm x 225mm
ARTHREX, INC.
AR-S3025-063-225
In Commercial Distribution

  • 00888867554269 ()
AR-S3025-063-225

  • Endoscopic-access dilator, reusable
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