| Primary Device ID | B030CP009320 |
| NIH Device Record Key | fb0bea01-0d45-4e85-acfb-e4470d36d1a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHROS |
| Version Model Number | CP-009-32 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030CP009320 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
[B030CP009320]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-02 |
| Device Publish Date | 2022-11-24 |
| B030ORT8595R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 95mm Lg. |
| B030ORT8595CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 95mm Lg. |
| B030ORT8595C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 95mm Lg. |
| B030ORT85950 | Ø8.5mm Polyaxial Pedicle Screw, 95mm Lg. |
| B030ORT8590R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 90mm Lg. |
| B030ORT8590CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 90mm Lg. |
| B030ORT8590C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 90mm Lg. |
| B030ORT85900 | Ø8.5mm Polyaxial Pedicle Screw, 90mm Lg. |
| B030ORT8585R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 85mm Lg. |
| B030ORT8585CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 85mm Lg. |
| B030ORT8585C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 85mm Lg. |
| B030ORT85850 | Ø8.5mm Polyaxial Pedicle Screw, 85mm Lg. |
| B030ORT8580R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 80mm Lg. |
| B030ORT8580CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 80mm Lg. |
| B030ORT8580C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 80mm Lg. |
| B030ORT85800 | Ø8.5mm Polyaxial Pedicle Screw, 80mm Lg. |
| B030ORT8575R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 75mm Lg. |
| B030ORT8575CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 75mm Lg. |
| B030ORT8575C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 75mm Lg. |
| B030ORT85750 | Ø8.5mm Polyaxial Pedicle Screw, 75mm Lg. |
| B030ORT8570R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 70mm Lg. |
| B030ORT8570CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 70mm Lg. |
| B030ORT8570C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 70mm Lg. |
| B030ORT85700 | Ø8.5mm Polyaxial Pedicle Screw, 70mm Lg. |
| B030ORT8565R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 65mm Lg. |
| B030ORT8565CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 65mm Lg. |
| B030ORT8565C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 65mm Lg. |
| B030ORT85650 | Ø8.5mm Polyaxial Pedicle Screw, 65mm Lg. |
| B030ORT8560R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 60mm Lg. |
| B030ORT8560CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 60mm Lg. |
| B030ORT8560C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 60mm Lg. |
| B030ORT85600 | Ø8.5mm Polyaxial Pedicle Screw, 60mm Lg. |
| B030ORT8555R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 55mm Lg. |
| B030ORT8555CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg. |
| B030ORT8555C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg. |
| B030ORT85550 | Ø8.5mm Polyaxial Pedicle Screw, 55mm Lg. |
| B030ORT8550R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 50mm Lg. |
| B030ORT8550CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 50mm Lg. |
| B030ORT8550C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 50mm Lg. |
| B030ORT85500 | Ø8.5mm Polyaxial Pedicle Screw, 50mm Lg. |
| B030ORT8545R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 45mm Lg. |
| B030ORT8545CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 45mm Lg. |
| B030ORT8545C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 45mm Lg. |
| B030ORT85450 | Ø8.5mm Polyaxial Pedicle Screw, 45mm Lg. |
| B030ORT8540R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 40mm Lg. |
| B030ORT8540CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 40mm Lg. |
| B030ORT8540C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 40mm Lg. |
| B030ORT85400 | Ø8.5mm Polyaxial Pedicle Screw, 40mm Lg. |
| B030ORT8535R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 35mm Lg. |
| B030ORT8535CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 35mm Lg. |