| Primary Device ID | M9432001740000 |
| NIH Device Record Key | 279bbaca-f23a-4794-9920-0d9d0d9567df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Liberty SI |
| Version Model Number | 20-0174-000 |
| 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 | M9432001740000 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
[M9432001740000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-15 |
| Device Publish Date | 2024-01-05 |
| M9431001250000 | Lateral SI Joint Fusion Implant 10mm Size F |
| M9431001240000 | Lateral SI Joint Fusion Implant 10mm Size E |
| M9431001230000 | Lateral SI Joint Fusion Implant 10mm Size D |
| M9431001220000 | Lateral SI Joint Fusion Implant 10mm Size C |
| M9431001210000 | Lateral Joint Fusion Implant 10mm Size B |
| M9431001200000 | Lateral SI Joint Fusion Implant 10mm Size A |
| M9431001160000 | Lateral SI Joint Fusion Implant 12mm Size G |
| M9431001150000 | Lateral SI Joint Fusion Implant 12mm Size F |
| M9431001140000 | Lateral SI Joint Fusion Implant 12mm Size E |
| M9431001130000 | Lateral SI Joint Fusion Implant 12mm Size D |
| M9431001120000 | Lateral SI Joint Fusion Implant 12mm Size C |
| M9431001110000 | Lateral SI Joint Fusion Implant 12mm Size B |
| M9431001100000 | Lateral SI Joint Fusion Implant 12mm Size A |
| M9432001760000 | Guidewire Protection Cap |
| M9432001740000 | Parallel Pin Placement Guide |
| M9432001710000 | Decortication Instrument |
| M9432001680000 | Drill (9.4mm) |
| M9432001670000 | Working Sleeve |
| M9432001660000 | Dilator 3 |
| M9432001650000 | Dilator 2 |
| M9432001640000 | Dilator 1 |
| M9432001630000 | Guidewire Extension |
| M9432001620010 | Guidewire, Trocar |
| M9432001620000 | Guidewire, Blunt |
| M9432001602040 | Spanner Nut Wrench |
| M9432001600000 | Insertion Instrument |
| M9433000230000 | Lateral SI Case/Lid |
| M9432001620030 | Stepped Guidewire, Trocar |
| M9432001620020 | Stepped Guidewire, Blunt |
| M9432001690000 | Drill (10.8mm) |
| M9432001680010 | Drill (9.4mm) Jacobs Connection |
| M9432001630010 | Guidewire Extension (470mm) |
| M9432001620050 | Short Guidewire, Trocar Sharp |
| M9432001620040 | Short Guidewire, Trocar |
| M9432001600010 | Ratcheting Inserter |