| Primary Device ID | M9432001860000 |
| NIH Device Record Key | da9a4c6f-8da7-40ac-a907-a59478fe781f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patriot SI |
| Version Model Number | 20-0186-000 |
| Company DUNS | 963359513 |
| Company Name | Spinal Simplicity, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M9432001860000 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
[M9432001860000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-21 |
| Device Publish Date | 2024-05-13 |
| M9432001940000 | Guidewire, Blunt |
| M9432001910000 | Impactor |
| M9432001900000 | Drillcorticator |
| M9432001890000 | Joint Sleeve |
| M9432001880000 | Joint Finder |
| M9432001860000 | Guidewire, Blunt |
| M9432001850000 | Insertion Instrument |
| M9430018700000 | Guidewire, Trocar |
| M9431001750000 | Posterior SI Joint Fusion Implant |
| M9432001990000 | Luer Insertion Instrument |
| M9433500070000 | Single Use Instrument Kit |