Glenoid IRI Leg (21mm) - The Glenoid IRI Leg (21mm) is a component of the - CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Duns Number:078667390

Device Description: The Glenoid IRI Leg (21mm) is a component of the Glenoid Intelligent Reusable Instrument ( The Glenoid IRI Leg (21mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (21mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

0006-0005-21

Brand Name

Glenoid IRI Leg (21mm)

Version/Model Number

L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KWS

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device Record Status

Public Device Record Key

69d081a9-0a09-4a6a-b651-0e0ecf031deb

Public Version Date

October 08, 2018

Public Version Number

5

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CUSTOM ORTHOPAEDIC SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25