| Primary Device ID | 00811771031533 |
| NIH Device Record Key | d8f5c36f-e0f2-4b12-bb42-e065f244bc79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patriot Spinal Fixation System |
| Version Model Number | 10-01-6035 |
| Company DUNS | 080841846 |
| Company Name | VALORUS SPINE 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811771031533 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
[00811771031533]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-24 |
| Device Publish Date | 2023-07-14 |
| 00811771033131 | Precontoured Rod, 120mm |
| 00811771033124 | Precontoured Rod, 110mm |
| 00811771033117 | Precontoured Rod, 95mm |
| 00811771033100 | Precontoured Rod, 85mm |
| 00811771033094 | Precontoured Rod, 75mm |
| 00811771033087 | Precontoured Rod, 65mm |
| 00811771033070 | Precontoured Rod, 55mm |
| 00811771033063 | Precontoured Rod, 45mm |
| 00811771033056 | Precontoured Rod, 35mm |
| 00811771033049 | Straight Rod, 95mm |
| 00811771033032 | Straight Rod, 85mm |
| 00811771033025 | Straight Rod, 75mm |
| 00811771033018 | Straight Rod, 65mm |
| 00811771033001 | Straight Rod, 55mm |
| 00811771032998 | Straight Rod, 45mm |
| 00811771032981 | Straight Rod, 35mm |
| 00811771032974 | Patriot Instrument Tray #2 |
| 00811771032967 | Patriot Instrument Tray #1 |
| 00811771032950 | Patriot Implant Tray |
| 00811771032943 | Guidewire, NiTi |
| 00811771032936 | Reduction Screwdriver |
| 00811771032929 | High Top Screw Tab Breaker |
| 00811771032912 | Rod Pusher |
| 00811771032905 | Rod Gripper |
| 00811771032899 | Crosslink Driver |
| 00811771032882 | Crosslink Torque Handle |
| 00811771032875 | Crosslink Caliper |
| 00811771032868 | Crosslink Inserter |
| 00811771032851 | Guidewire, SS |
| 00811771032844 | Ratcheting T-Handle |
| 00811771032837 | Ratcheting Axial Handle |
| 00811771032820 | Final Tightener |
| 00811771032813 | Final Tightening Driver |
| 00811771032806 | Counter-Torque |
| 00811771032790 | Rod Reducer |
| 00811771032783 | Rod Rocker |
| 00811771032776 | In-Situ Bender, Left |
| 00811771032769 | In-Situ Bender, Right |
| 00811771032752 | Distractor |
| 00811771032745 | Compressor |
| 00811771032738 | Rod Holder |
| 00811771032721 | Rod Bender |
| 00811771032714 | Rod Template, 400mm |
| 00811771032707 | Head Adjuster |
| 00811771032691 | Static Driver |
| 00811771032684 | Screw Driver |
| 00811771032677 | Tap, 8.0 |
| 00811771032660 | Tap, 7.0 |
| 00811771032653 | Tap, 6.0 |
| 00811771032646 | Tap, 5.0 |