| Primary Device ID | 03662663154147 |
| NIH Device Record Key | 39ecb088-9834-4e8f-96c2-902f1f4d087c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System |
| Version Model Number | 14-525502-01 |
| Catalog Number | 14-525502-01 |
| 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 | |
| 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 | 03662663154147 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
[03662663154147]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-25 |
| Device Publish Date | 2025-11-17 |
| 03662663146654 | LINEUM 3.5MM X 40MM COCR ROD |
| 03662663146647 | LINEUM 3.5MM X 40MM TI ROD |
| 03662663146630 | LINEUM 3.5MM X 40MM TI ROD |
| 03662663154352 | LID, CURVED ROD CADDY |
| 03662663154345 | BASE, LINEUM SUPP TRAY |
| 03662663154338 | CURVED ROD CADDY, LINEUM |
| 03662663154321 | TRAY, LINEUM SUPP TRAY |
| 03662663154314 | Lineum® Supplemental Tray |
| 03662663154307 | LID, PLUG CADDY, LINEUM |
| 03662663154291 | LID, 4.35 SCREW CADDY, LINEUM |
| 03662663154284 | LID, 4.0 SCREW CADDY, LINEUM |
| 03662663154277 | LID, 3.5 SCREW CADDY, LINEUM |
| 03662663154260 | PLUG CADDY, LINEUM |
| 03662663154253 | 4.35 SCREW CADDY, LINEUM |
| 03662663154246 | 4.0 SCREW CADDY, LINEUM |
| 03662663154239 | 3.5 SCREW CADDY, LINEUM |
| 03662663154222 | TRAY, LINEUM STANDARD IMPLANT |
| 03662663154215 | Lineum® Std Implant Tray |
| 03662663154208 | PLATE CADDY, LINEUM OCCIPITAL |
| 03662663154192 | SCREW CADDY, LINEUM OCCIPITAL |
| 03662663154185 | BASE LINEUM OCCIPITAL IMP/INST |
| 03662663154178 | TRAY LINEUM OCCIPITAL IMP/INST |
| 03662663154161 | Lineum® Occipital Imp/Inst Tray |
| 03662663154154 | BASE, LINEUM STANDARD INST. B |
| 03662663154147 | TRAY, LINEUM STANDARD INST. B |
| 03662663154130 | Lineum® Std Inst. Tray B |
| 03662663154123 | BASE, LINEUM STANDARD INST. A |
| 03662663154116 | TRAY, LINEUM STANDARD INST. A |
| 03662663154109 | Lineum® Std Inst. Tray A |
| 03662663154093 | BASE, LINEUM STANDARD IMPLANT |
| 03662663154086 | ACCESSORY CADDY, LINEUM |
| 03662663154079 | 3.5 SMOOTH SCREW CADDY, LINEUM |
| 03662663154062 | 4.35 SCREW CADDY, LINEUM |
| 03662663154055 | 4.0 SCREW CADDY, LINEUM |
| 03662663154048 | 3.5 SCREW CADDY, LINEUM |
| 03662663154031 | TRAY, LINEUM STANDARD IMPLANT |
| 03662663154024 | Lineum® Std Impl Surgical Tray |
| 03662663154017 | 8.0X56MM CROSS-CONNECTOR |
| 03662663154000 | 8.0X49MM CROSS-CONNECTOR |
| 03662663153997 | 8.0X42MM CROSS-CONNECTOR |
| 03662663153980 | 8.0X35MM CROSS-CONNECTOR |
| 03662663153973 | 6.5X28MM CROSS-CONNECTOR |
| 03662663153966 | 6.5X23MM CROSS-CONNECTOR |
| 03662663153959 | 6.0X56MM CROSS-CONNECTOR |
| 03662663153942 | 6.0X49MM CROSS-CONNECTOR |
| 03662663153935 | 6.0X42MM CROSS-CONNECTOR |
| 03662663153928 | 6.0X35MM CROSS-CONNECTOR |
| 03662663153911 | 4.5X28MM CROSS-CONNECTOR |
| 03662663153904 | 4.5X25MM CROSS-CONNECTOR |
| 03662663153874 | LINEUM 6-32MM TAP GUIDE |