| Primary Device ID | B030ORTNAVAWL8500 |
| NIH Device Record Key | 70bff107-be66-4b9d-aa51-fc3e8e12f5d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navigation Instrument |
| Version Model Number | ORT-NAV-AWL-8500 |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030ORTNAVAWL8500 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
[B030ORTNAVAWL8500]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-11 |
| Device Publish Date | 2022-11-03 |
| B030ORTNAVPROBE003 | Pedicle Probe, Duckbill, NAV Handle |
| B030ORTNAVPROBE001 | Pedicle Probe, Lenke, Straight, NAV Handle |
| B030ORTNAVPEDAWL001 | Pedicle Awl, Navigation |
| B030ORTNAVAWL8500 | 8.5 mm Awl Tap, Navigation |
| B030ORTNAVAWL7500 | 7.5 mm Awl Tap, Navigation |
| B030ORTNAVAWL6500 | 6.5 mm Awl Tap, Navigation |
| B030ORTNAVAWL5500 | 5.5 mm Awl Tap, Navigation |
| B030ORTNAVAWL4500 | 4.5 mm Awl Tap, Navigation |
| B030ORTNAVAWL4000 | 4.0 mm Awl Tap, Navigation |
| B030ORTNAV8501 | 8.5 mm Tap, Open Cannulated, Navigation |
| B030ORTNAV8500 | 8.5 mm Tap, Open Solid, Navigation |
| B030ORTNAV7501 | 7.5 mm Tap, Open Cannulated, Navigation |
| B030ORTNAV7500 | 7.5 mm Tap, Open Solid, Navigation |
| B030ORTNAV6501 | 6.5 mm Tap, Open Cannulated, Navigation |
| B030ORTNAV6500 | 6.5 mm Tap, Open Solid, Navigation |
| B030ORTNAV5501 | 5.5 mm Tap, Open Cannulated, Navigation |
| B030ORTNAV5500 | 5.5 mm Tap, Open Solid, Navigation |
| B030ORTNAV4501 | 4.5 mm Tap, Open Cannulated, Navigation |
| B030ORTNAV4500 | 4.5 mm Tap, Open Solid, Navigation |
| B030ORTNAV4000 | 4.0 mm Tap, Open Solid, Navigation |
| B030ORMNAV8501 | 8.5 mm Tap, MIS Solid, Navigation |
| B030ORMNAV8500 | 8.5 mm Tap, MIS Cannulated, Navigation |
| B030ORMNAV7501 | 7.5 mm Tap, MIS Solid, Navigation |
| B030ORMNAV7500 | 7.5 mm Tap, MIS Cannulated, Navigation |
| B030ORMNAV6501 | 6.5 mm Tap, MIS Solid, Navigation |
| B030ORMNAV6500 | 6.5 mm Tap, MIS Cannulated, Navigation |
| B030ORMNAV5501 | 5.5 mm Tap, MIS Solid, Navigation |
| B030ORMNAV5500 | 5.5 mm Tap, MIS Cannulated, Navigation |
| B030ORMNAV5000 | 5.0 mm Tap, MIS Cannulated, Navigation |
| B030ORMNAV4501 | 4.5 mm Tap, MIS Solid, Navigation |
| B030NAVNEO8500 | 8.5 mm Tap, NEO Solid, Navigation |
| B030NAVNEO8000 | 8.0 mm Tap, NEO Solid, Navigation |
| B030NAVNEO7500 | 7.5 mm Tap, NEO Solid, Navigation |
| B030NAVNEO7000 | 7.0 mm Tap, NEO Solid, Navigation |
| B030NAVNEO6500 | 6.5 mm Tap, NEO Solid, Navigation |
| B030NAVNEO6000 | 6.0 mm Tap, NEO Solid, Navigation |
| B030NAVNEO5500 | 5.5 mm Tap, NEO Solid, Navigation |
| B030NAVNEO5000 | 5.0 mm Tap, NEO Solid, Navigation |
| B030NAVNEO4500 | 4.5 mm Tap, NEO Solid, Navigation |
| B030NAVNEO4000 | 4.0 mm Tap, NEO Solid, Navigation |
| B030NAVNEO11701 | NEO Screwdriver, Solid, Navigation |
| B030NAV50000102 | Navigation Tray 2 |
| B030NAV50000101 | Navigation Tray 1 |
| B030NAV1170501 | QT Driver 1 of 2, Navigation |
| B030NAV11704 | MIS Polyaxial Cannulated Screwdriver, T25, Navigation |
| B030NAV11702 | MIS Polyaxial Screwdriver, T25, Navigation |