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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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The Glenoid IRI Leg (17mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (17mm) 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

  • 00811813020112 ()

  • Radial Length from Device Axis ("Foot"): 17mm
0006-0005-17

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (16mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (16mm) 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

  • 00811813020105 ()

  • Length: 16 Millimeter
0006-0005-16

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (15mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (15mm) 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

  • 00811813020099 ()

  • Radial Length from Device Axis ("Foot"): 15mm
0006-0005-15

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (14mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (14mm) 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

  • 00811813020082 ()

  • Length: 14 Millimeter
0006-0005-14

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (13mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (13mm) 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

  • 00811813020075 ()

  • Length: 13 Millimeter
0006-0005-13

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (12mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (12mm) 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

  • 00811813020068 ()

  • Length: 12 Millimeter
0006-0005-12

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (11mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (11mm) 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

  • 00811813020051 ()

  • Length: 11 Millimeter
0006-0005-11

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (10mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (10mm) 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

  • 00811813020044 ()

  • Length: 10 Millimeter
0006-0005-10

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
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
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
No Description
DSM BIOMEDICAL, INC.
30030-02
In Commercial Distribution

  • 00812337020022 ()

  • Length: 8 Centimeter
  • Width: 6 Centimeter
ABS-30002S

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
No Description
DSM BIOMEDICAL, INC.
30030-01
In Commercial Distribution

  • 00812337020015 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter
ABS-30001S

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
No Description
Provision
AR-1204R-08S
In Commercial Distribution

  • B504OMAR1204R08S0 ()


  • Burring power tool attachment
No Description
Provision
AR-1204R-085S
In Commercial Distribution

  • B504OMAR1204R085S0 ()


  • Burring power tool attachment
No Description
Provision
AR-1204L
In Commercial Distribution

  • B504OMAR1204L0 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-1204F-24I
In Commercial Distribution

  • B504OMAR1204F24I0 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-1204D
In Commercial Distribution

  • B504OMAR1204D0 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-1204AF-70
In Commercial Distribution

  • B504OMAR1204AF700 ()


  • Burring power tool attachment
No Description
Provision
AR-1204AF-115
In Commercial Distribution

  • B504OMAR1204AF1150 ()


  • Burring power tool attachment
No Description
Provision
AR1204.5L
In Commercial Distribution

  • B504OMAR12045L0 ()


  • Drilling power tool attachment, basic
No Description
Provision
ABS-8981-10S
In Commercial Distribution

  • B504OMABS898110S0 ()


  • Drilling power tool attachment, basic
No Description
Provision
ABS-8981-06S
In Commercial Distribution

  • B504OMABS898106S0 ()


  • Drilling power tool attachment, basic
No Description
Provision
ABS-4085D-S
In Commercial Distribution

  • B504OMABS4085DS0 ()


  • Drilling power tool attachment, basic
No Description
Provision
ABS-4057D-275
In Commercial Distribution

  • B504OMABS4057D2750 ()


  • Drilling power tool attachment, basic
No Description
Provision
ABS-4057D-25
In Commercial Distribution

  • B504OMABS4057D250 ()


  • Drilling power tool attachment, basic
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