| Primary Device ID | B030ORM55400 |
| NIH Device Record Key | 883e75b7-5da2-492d-9b01-28b4e56c1507 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthros MIS |
| Version Model Number | ORM-5540 |
| 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 | true |
| 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 |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030ORM55400 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
[B030ORM55400]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-05 |
| Device Publish Date | 2019-01-30 |
| B030ORM95C0 | Ø5.5mm Curved Rod 95mm Lg. |
| B030ORM90C0 | Ø5.5mm Curved Rod 90mm Lg. |
| B030ORM85C0 | Ø5.5mm Curved Rod 85mm Lg. |
| B030ORM8595L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower |
| B030ORM85950 | Ø8.5mm MIS Polyaxial Pedicle Screw, 95mm |
| B030ORM8590L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower |
| B030ORM85900 | Ø8.5mm MIS Polyaxial Pedicle Screw, 90mm |
| B030ORM8585L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower |
| B030ORM85850 | Ø8.5mm MIS Polyaxial Pedicle Screw, 85mm |
| B030ORM8580L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower |
| B030ORM85800 | Ø8.5mm MIS Polyaxial Pedicle Screw, 80mm |
| B030ORM8575L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower |
| B030ORM85750 | Ø8.5mm MIS Polyaxial Pedicle Screw, 75mm |
| B030ORM8570L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower |
| B030ORM85700 | Ø8.5mm MIS Polyaxial Pedicle Screw, 70mm |
| B030ORM8565L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 65mm Lg. Long Tower |
| B030ORM85650 | Ø8.5mm MIS Polyaxial Pedicle Screw, 65mm |
| B030ORM8560L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 60mm Lg. Long Tower |
| B030ORM85600 | Ø8.5mm MIS Polyaxial Pedicle Screw, 60mm |
| B030ORM8555L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 55mm Lg. Long Tower |
| B030ORM85550 | Ø8.5mm MIS Polyaxial Pedicle Screw, 55mm |
| B030ORM8550L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 50mm Lg. Long Tower |
| B030ORM85500 | Ø8.5mm MIS Polyaxial Pedicle Screw, 50mm |
| B030ORM8545L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 45mm Lg. Long Tower |
| B030ORM85450 | Ø8.5mm MIS Polyaxial Pedicle Screw, 45mm |
| B030ORM8540L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 40mm Lg. Long Tower |
| B030ORM85400 | Ø8.5mm MIS Polyaxial Pedicle Screw, 40mm |
| B030ORM8535L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 35mm Lg. Long Tower |
| B030ORM85350 | Ø8.5mm MIS Polyaxial Pedicle Screw, 35mm |
| B030ORM8530L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 30mm Lg. Long Tower |
| B030ORM85300 | Ø8.5mm MIS Polyaxial Pedicle Screw, 30mm |
| B030ORM85110L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 110mm Lg. Long Tower |
| B030ORM851100 | Ø8.5mm MIS Polyaxial Pedicle Screw, 110mm |
| B030ORM85105L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 105mm Lg. Long Tower |
| B030ORM851050 | Ø8.5mm MIS Polyaxial Pedicle Screw, 105mm |
| B030ORM85100L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 100mm Lg. Long Tower |
| B030ORM851000 | Ø8.5mm MIS Polyaxial Pedicle Screw, 100mm |
| B030ORM80C0 | Ø5.5mm Curved Rod 80mm Lg. |
| B030ORM75C0 | Ø5.5mm Curved Rod 75mm Lg. |
| B030ORM7595L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower |
| B030ORM75950 | Ø7.5mm MIS Polyaxial Pedicle Screw, 95mm |
| B030ORM7590L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower |
| B030ORM75900 | Ø7.5mm MIS Polyaxial Pedicle Screw, 90mm |
| B030ORM7585L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower |
| B030ORM75850 | Ø7.5mm MIS Polyaxial Pedicle Screw, 85mm |
| B030ORM7580L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower |
| B030ORM75800 | Ø7.5mm MIS Polyaxial Pedicle Screw, 80mm |
| B030ORM7575L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower |
| B030ORM75750 | Ø7.5mm MIS Polyaxial Pedicle Screw, 75mm |
| B030ORM7570L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower |