| Primary Device ID | 03662663137157 |
| NIH Device Record Key | 3a78cca2-a3ff-47a3-96df-3e5c9684b32c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polaris 4.75 Deformity System |
| Version Model Number | 14-510070 |
| Catalog Number | 14-510070 |
| Company DUNS | 119260394 |
| Company Name | Highridge Medical, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663137157 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663137157]
Moist Heat or Steam Sterilization
[03662663137157]
Moist Heat or Steam Sterilization
[03662663137157]
Moist Heat or Steam Sterilization
[03662663137157]
Moist Heat or Steam Sterilization
[03662663137157]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-24 |
| Device Publish Date | 2025-11-14 |
| 03662663180405 | Paddle Shaver 8 mm |
| 03662663180399 | 4.75 TI CLSD DOMINO, 4.75/6.35 |
| 03662663180382 | Paddle Shaver 6 mm |
| 03662663180375 | BUTTON SPRING ASSEMBLY |
| 03662663180368 | 5.5 HA Multi Screw X.XX x XXX mm |
| 03662663180351 | 5.5 HA MULTI SCREW 8.5 X100MM |
| 03662663180344 | 4.75 X 6.35MM OPEN-OPEN SADDLE |
| 03662663180337 | 4.75 X 5.5MM OPEN-OPEN SADDLE |
| 03662663180320 | 4.75 X 4.75MM OPEN-OPEN SADDLE |
| 03662663180313 | 5.5 HA MULTI SCREW 8.5 X 80MM |
| 03662663180306 | 5.5 HA MULTI SCREW 8.5 X 75MM |
| 03662663140850 | LID, SURGICAL TRAY |
| 03662663137379 | SMALL CURVED THORACIC PROBE |
| 03662663137362 | CURVED LUMBAR PROBE |
| 03662663137355 | STRAIGHT THORACIC PROBE |
| 03662663137348 | CURVED THORACIC PROBE |
| 03662663137317 | 4.75 TI ROD PERSUADER |
| 03662663137294 | 4.75 TI PEDICLE SOUND, STIFF |
| 03662663137287 | 4.75 TI PEDICLE SOUND, MEDIUM |
| 03662663137270 | CURVED HOOK STARTER |
| 03662663137263 | 4.75 TI UNIV HOOK STARTER, 90 |
| 03662663137256 | 4.75 TI MALLEABLE TRIAL ROD |
| 03662663137249 | 4.75 TI CROSS CONN TORQ WRENCH |
| 03662663137232 | 4.75 TI CROSS CONN TEMPLATE |
| 03662663137225 | 4.75 TI UNIV HOOK STARTER, 45 |
| 03662663137218 | 4.75 TI THORACIC HOOK STARTER |
| 03662663137201 | 4.75 TI laminar HOOK STARTER |
| 03662663137195 | 4.75 TI C-CLAMP HOLDER |
| 03662663137188 | 4.75 TI HOOK IMPACTOR |
| 03662663137171 | 4.75 TI ANGLED HOOK HOLDER |
| 03662663137164 | 4.75 TI VERTICAL HOOK HOLDER |
| 03662663137157 | 4.75 TI SIDE HOOK HOLDER |
| 03662663137119 | 4.75 TI PLUG DRIVER |
| 03662663137102 | 4.75 TI PLUG STARTER |
| 03662663137096 | 4.75 TI MAS INSERTER |
| 03662663137089 | 4.75 TI TORQUE STABILIZER OPEN |
| 03662663137072 | 4.75 TI SMALL CURVED PROBE |
| 03662663137065 | 4.75 TI ROD HEX DRIVER |
| 03662663137058 | 4.75 TI ROD HOLDER |
| 03662663137041 | 4.75 TI ROD MANIPULATOR |
| 03662663137034 | 4.75 TI IN SLOT DISTRACTOR |
| 03662663137027 | 4.75 TI ANCHOR CLAMP |
| 03662663137010 | 4.75 TI CLSD HEAD MAS INSERTER |
| 03662663137003 | 4.75 TI FIXED SCREW INSERTER |
| 03662663136990 | 4.75 TI MAS INSERTER |
| 03662663136983 | 4.75 TI RATCHET TORQUE HANDLE |
| 03662663136976 | 4.75 TI AWL |
| 03662663136969 | 4.75 TI 6.5 MM TAP |
| 03662663136952 | 4.75 TI 6.0 MM TAP |
| 03662663136945 | 4.75 TI 5.5 MM TAP |