| Primary Device ID | 00850046497049 |
| NIH Device Record Key | 8e647de9-d814-4c8a-af2d-033b0ff18a25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STELLAR Knee |
| Version Model Number | Revision 02 |
| Catalog Number | 30-0016 |
| Company DUNS | 035071717 |
| Company Name | POLARISAR, 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850046497049 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
[00850046497049]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-11 |
| Device Publish Date | 2025-03-03 |
| 00850046497162 | Kit, Observer Head Mounted Device, V2 |
| 00850046497155 | Kit, Streaming Head Mounted Device, V2 |
| 00850046497148 | Kit, Head Mounted Device, V2 |
| 00850046497131 | STELLAR Knee Application, V2 |
| 00850046497124 | Kit, Streaming Head Mounted Device |
| 00850046497117 | Kit, Head Mounted Device |
| 00850046497100 | STELLAR Knee Application |
| 00850046497087 | HAND DRIVER |
| 00850046497070 | HUDSON ADAPTER |
| 00850046497063 | PROXIMAL TIBIA RESECTION BLOCK - RIGHT |
| 00850046497056 | PROXIMAL TIBIA RESECTION BLOCK - LEFT |
| 00850046497049 | DISTAL FEMUR RESECTION BLOCK |
| 00850046497032 | Universal Resection Guide |
| 00850046497025 | STELLAR Knee Reusable Instrumentation |
| 00850046497018 | Kit, Total Knee, Right |
| 00850046497001 | Kit, Total Knee, Left |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STELLAR KNEE 98567849 not registered Live/Pending |
PolarisAR, Inc, 2024-05-24 |