DEVICE: Glenoid IRI Leg (24mm) (00811813020181)
Device Identifier (DI) Information
Glenoid IRI Leg (24mm)
L
Not in Commercial Distribution
0006-0005-24
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution
0006-0005-24
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
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).
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
59009 | Orthopaedic implant/instrument assembling device |
A non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
13180 | Orthopaedic prosthesis implantation positioning instrument, reusable |
A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
PHX | Shoulder Prosthesis, Reverse Configuration |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a dry, dark, cool place |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 24 Millimeter |
Device Record Status
d9bcf60f-a5ee-4c21-8d07-5e675a255508
March 12, 2024
7
September 02, 2016
March 12, 2024
7
September 02, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
2168005905
info@customorthopaedics.com
info@customorthopaedics.com