| Primary Device ID | 00850046497186 |
| NIH Device Record Key | 7736d8c6-7e25-4ee4-9411-58a9ca6f024f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruFix Pin Kit |
| Version Model Number | 80-0005 |
| Catalog Number | 80-0005 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 800-903-6894 |
| customerservice@thinkpolaris.com | |
| Phone | 800-903-6894 |
| customerservice@thinkpolaris.com | |
| Phone | 800-903-6894 |
| customerservice@thinkpolaris.com | |
| Phone | 800-903-6894 |
| customerservice@thinkpolaris.com | |
| Phone | 800-903-6894 |
| customerservice@thinkpolaris.com | |
| Phone | 800-903-6894 |
| customerservice@thinkpolaris.com | |
| Phone | 800-903-6894 |
| customerservice@thinkpolaris.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850046497186 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850046497186]
Radiation Sterilization
[00850046497186]
Radiation Sterilization
[00850046497186]
Radiation Sterilization
[00850046497186]
Radiation Sterilization
[00850046497186]
Radiation Sterilization
[00850046497186]
Radiation Sterilization
[00850046497186]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-24 |
| Device Publish Date | 2025-06-16 |
| 00850046497179 - STELLAR Knee Marker Kit | 2025-06-24 For use with TruFix Pin Kit (80-0005) |
| 00850046497186 - TruFix Pin Kit | 2025-06-24TruFix Pin Kit for use with 80-0006 STELLAR Knee Marker Kit |
| 00850046497186 - TruFix Pin Kit | 2025-06-24 TruFix Pin Kit for use with 80-0006 STELLAR Knee Marker Kit |
| 00850046497193 - Right Femur - Left Tibia Arm Assembly | 2025-06-24 For Use with 80-0006. |
| 00850046497209 - Left Femur - Right Tibia Arm Assembly | 2025-06-24 For Use with 80-0006. |
| 00850046497001 - STELLAR Knee | 2025-03-11 Kit, Total Knee, Left |
| 00850046497018 - STELLAR Knee | 2025-03-11 Kit, Total Knee, Right |
| 00850046497025 - STELLAR Knee | 2025-03-11 STELLAR Knee Reusable Instrumentation |
| 00850046497032 - STELLAR Knee | 2025-03-11 Universal Resection Guide |