Primary Device ID | M9432001680000 |
NIH Device Record Key | 01e6c0c1-b03c-4e2d-ae76-6d2fb25997a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Liberty SI |
Version Model Number | 20-0168-000 |
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 | M9432001680000 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
Moist Heat or Steam Sterilization
[M9432001680000]
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 |