| Primary Device ID | 00811813020235 |
| NIH Device Record Key | 46a70ae7-2183-4098-9427-d1a49aeb29e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartBone |
| Version Model Number | A |
| Catalog Number | 0006-0007-UPI |
| Company DUNS | 078667390 |
| Company Name | CUSTOM ORTHOPAEDIC SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811813020235 [Primary] |
| PHX | Shoulder Prosthesis, Reverse Configuration |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
[00811813020235]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-09-02 |
| 00811813020525 - VisionAir 3D Stent | 2024-03-19 Patient-Specific Silicone Airway Stent |
| 00811813020020 - Glenoid IRIS Surgical Tray | 2019-08-09 The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that contains all of the Arthrex Glenoid IRI |
| 00811813020235 - SmartBone | 2019-02-07The 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). |
| 00811813020235 - SmartBone | 2019-02-07 The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at |
| 00811813020006 - Glenoid IRI Handle | 2018-10-08 The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assem |
| 00811813020013 - Glenoid IRI Barrel | 2018-10-08 The Glenoid IRI Barrel is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly i |
| 00811813020037 - Glenoid IRI Cap | 2018-10-08 The Glenoid IRI Cap is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly is i |
| 00811813020044 - Glenoid IRI Leg (10mm) | 2018-10-08 The Glenoid IRI Leg (10mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (10mm) is i |
| 00811813020051 - Glenoid IRI Leg (11mm) | 2018-10-08 The Glenoid IRI Leg (11mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (11mm) is i |