| Primary Device ID | B030ORT155650 |
| NIH Device Record Key | 248855a9-8fe5-47bb-81fb-8b1946e2df42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHROS Open |
| Version Model Number | ORT-1-5565 |
| Catalog Number | NA |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030ORT155650 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
[B030ORT155650]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-15 |
| Device Publish Date | 2024-05-07 |
| B030ORT165950 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 95mm |
| B030ORT165900 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 90mm |
| B030ORT165850 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 85mm |
| B030ORT165800 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 80mm |
| B030ORT165750 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 75mm |
| B030ORT165700 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 70mm |
| B030ORT165650 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 65mm |
| B030ORT165600 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 60mm |
| B030ORT165550 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 55mm |
| B030ORT165500 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 50mm |
| B030ORT165450 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 45mm |
| B030ORT165400 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 40mm |
| B030ORT165350 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 35mm |
| B030ORT165300 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 30mm |
| B030ORT165250 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 25mm |
| B030ORT1651100 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 110mm |
| B030ORT1651050 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 105mm |
| B030ORT1651000 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 100mm |
| B030ORT155800 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 80mm |
| B030ORT155750 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 75mm |
| B030ORT155700 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 70mm |
| B030ORT155650 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 65mm |
| B030ORT155600 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 60mm |
| B030ORT155550 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 55mm |
| B030ORT155500 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 50mm |
| B030ORT155450 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 45mm |
| B030ORT155400 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 40mm |
| B030ORT155350 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 35mm. |
| B030ORT155300 | Ø5.5mm Polyaxially Screw, Orthros Upgrade, 30mm |
| B030ORT155250 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 25mm |
| B030ORT185950 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 95mm |
| B030ORT185900 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 90mm |
| B030ORT185850 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 85mm |
| B030ORT185800 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 80mm |
| B030ORT185750 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 75mm |
| B030ORT185700 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 70mm |
| B030ORT185650 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 65mm |
| B030ORT185600 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 60mm |
| B030ORT185550 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 55mm |
| B030ORT185500 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 50mm |
| B030ORT185450 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 45mm |
| B030ORT185400 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 40mm |
| B030ORT185350 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 35mm |
| B030ORT185300 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 30mm |
| B030ORT185250 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 25mm |
| B030ORT1851100 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 110mm |
| B030ORT1851050 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 105mm |
| B030ORT1851000 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 100mm |
| B030ORT175950 | Ø7.5mm Polyaxial Screw, Orthros Upgrade, 95mm |
| B030ORT175900 | Ø7.5mm Polyaxial Screw, Orthros Upgrade, 90mm |