| Primary Device ID | 00858704006350 |
| NIH Device Record Key | 30ea558f-8fca-43ab-831f-d7a7f68ddc2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KneeAlign2 |
| Version Model Number | 402045 |
| Catalog Number | 402045 |
| Company DUNS | 023266163 |
| Company Name | ORTHALIGN, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858704006350 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
[00858704006350]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-17 |
| Device Publish Date | 2016-09-23 |
| 00810832031895 - Lantern | 2024-12-23 28mm Liner Registration Trial |
| 00810832031901 - Lantern | 2024-12-23 32mm Liner Registration Trial |
| 00810832031918 - Lantern | 2024-12-23 36mm Liner Registration Trial |
| 00810832031925 - Lantern | 2024-12-23 40mm Liner Registration Trial |
| 00810832031932 - Lantern | 2024-12-23 44mm Liner Registration Trial |
| 00810832032014 - Lantern | 2024-12-23 Reference Sensor (RS), Lantern Hip |
| 00810832032021 - Lantern | 2024-12-23 Femur Sensor (FS), Lantern Hip |
| 00810832032038 - Lantern | 2024-12-23 Registration Wand |