| Primary Device ID | 03662663170512 |
| NIH Device Record Key | 6cc60e3a-f515-4bc4-90e0-c815630be4a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polaris 5.5 Spinal Fixation System |
| Version Model Number | 14-578820 |
| Catalog Number | 14-578820 |
| Company DUNS | 119260394 |
| Company Name | Highridge Medical, LLC |
| 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 | false |
| 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 |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663170512 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663170512]
Moist Heat or Steam Sterilization
[03662663170512]
Moist Heat or Steam Sterilization
[03662663170512]
Moist Heat or Steam Sterilization
[03662663170512]
Moist Heat or Steam Sterilization
[03662663170512]
Moist Heat or Steam Sterilization
[03662663170512]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-21 |
| Device Publish Date | 2025-11-13 |
| 03662663170840 | 5.5 TI 10.5X100MM TRANS REDUC |
| 03662663170833 | 5.5 TI 10.5 X100MM TRANSLATION |
| 03662663170819 | 5.5 TI 10.5 X 95MM TRANSLATION |
| 03662663170796 | 5.5 TI 10.5 X 90MM TRANSLATION |
| 03662663170772 | 5.5 TI 10.5 X 85MM TRANSLATION |
| 03662663170758 | 5.5 TI 10.5 X 80MM TRANSLATION |
| 03662663170734 | 5.5 TI 10.5 X 75MM TRANSLATION |
| 03662663170710 | 5.5 TI 10.5 X 70MM TRANSLATION |
| 03662663170697 | 5.5 TI 10.5 X 65MM TRANSLATION |
| 03662663170673 | 5.5 TI 10.5 X 60MM TRANSLATION |
| 03662663170659 | 5.5 TI 10.5 X 55MM TRANSLATION |
| 03662663170635 | 5.5 TI 10.5 X 50MM TRANSLATION |
| 03662663170628 | 5.5 TI 10.5X45MM TRANS REDUC |
| 03662663170611 | 5.5 TI 10.5 X 45MM TRANSLATION |
| 03662663170604 | 5.5 TI 10.5X40MM TRANS REDUC |
| 03662663170598 | 5.5 TI 10.5 X 40MM TRANSLATION |
| 03662663170581 | 5.5 TI 10.5X35MM TRANS REDUC |
| 03662663170574 | 5.5 TI 10.5 X 35MM TRANSLATION |
| 03662663170567 | 5.5 TI 10.5X30MM TRANS REDUC |
| 03662663170550 | 5.5 TI 10.5 X 30MM TRANSLATION |
| 03662663170543 | 5.5 TI 10.5X25MM TRANS REDUC |
| 03662663170536 | 5.5 TI 10.5 X 25MM TRANSLATION |
| 03662663170529 | 5.5 TI 10.5X20MM TRANS REDUC |
| 03662663170512 | 5.5 TI 10.5 X 20MM TRANSLATION |
| 03662663170505 | 5.5 TI 10.5X150MM TRANS REDUC |
| 03662663170499 | 5.5 TI 10.5 X150MM TRANSLATION |
| 03662663170482 | 5.5 TI 10.5X145MM TRANS REDUC |
| 03662663170475 | 5.5 TI 10.5 X145MM TRANSLATION |
| 03662663170468 | 5.5 TI 10.5X140MM TRANS REDUC |
| 03662663170451 | 5.5 TI 10.5 X140MM TRANSLATION |
| 03662663170444 | 5.5 TI 10.5X135MM TRANS REDUC |
| 03662663170437 | 5.5 TI 10.5 X135MM TRANSLATION |
| 03662663170420 | 5.5 TI 10.5X130MM TRANS REDUC |
| 03662663170413 | 5.5 TI 10.5 X130MM TRANSLATION |
| 03662663170406 | 5.5 TI 10.5X125MM TRANS REDUC |
| 03662663170390 | 5.5 TI 10.5 X125MM TRANSLATION |
| 03662663170383 | 5.5 TI 10.5X120MM TRANS REDUC |
| 03662663170376 | 5.5 TI 10.5 X120MM TRANSLATION |
| 03662663170369 | 5.5 TI 10.5X115MM TRANS REDUC |
| 03662663170352 | 5.5 TI 10.5 X115MM TRANSLATION |
| 03662663170345 | 5.5 TI 10.5X110MM TRANS REDUC |
| 03662663170338 | 5.5 TI 10.5 X110MM TRANSLATION |
| 03662663170321 | 5.5 TI 10.5X105MM TRANS REDUC |
| 03662663170314 | 5.5 TI 10.5 X105MM TRANSLATION |
| 03662663170291 | 5.5 TI 9.5 X 100MM TRANSLATION |
| 03662663170284 | 5.5 TI 9.5X95MM TRANS REDUC |
| 03662663170277 | 5.5 TI 9.5 X 95MM TRANSLATION |
| 03662663170260 | 5.5 TI 9.5X90MM TRANS REDUC |
| 03662663170253 | 5.5 TI 9.5 X 90MM TRANSLATION |
| 03662663170246 | 5.5 TI 9.5X85MM TRANS REDUC |