| Primary Device ID | M7404400032 |
| NIH Device Record Key | 50212090-196b-4837-89f1-494ec804e42b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VIA Spinous Process Fixation System |
| Version Model Number | 34-03-03 |
| Catalog Number | 440-0032 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| 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(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7404400032 [Primary] |
| PEK | Spinous process plate |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
[M7404400032]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2015-02-25 |
| M7404400046 | Sterilzation Tray Base |
| M7404400042 | 7mm Dilator |
| M7404400041 | 17mm Modular Inserter |
| M7404400040 | 15mm Modular Inserter |
| M7404400039 | 13mm Modular Inserter |
| M7404400038 | 11mm Modular Inserter |
| M7404400037 | 9mm Modular Inserter |
| M7404400036 | Removal Tool |
| M7404400035 | 17mm Rasp |
| M7404400034 | 15mm Rasp |
| M7404400033 | 11mm Rasp |
| M7404400032 | 3" Distractor |
| M7404400030 | Final Tightner |
| M7404400028 | Implant Compressor |
| M7404400027 | Sterilzation Tray Base |
| M7404400026 | Sterilzation Pullout Tray |
| M7404400024 | Sterilization Lid |
| M7404400023 | Implant Inserter |
| M7404400022 | Implant Setting Block |
| M7404400021 | 5mm Dilator |
| M7404400020 | 13mm Rasp |
| M7404400019 | 9mm Rasp |
| M7404400018 | Trox Driver |
| M7404400015 | 17mm Trial |
| M7404400014 | 15mm Trial |
| M7404400013 | 13mm Trial |
| M7404400012 | 11mm Trial |
| M7404400011 | 9mm Trial |
| M7404400006 | Left and Right Female Plate |
| M7404400005 | Male Plate |
| M7404400004 | Male Plate |
| M7404400003 | Male Plate |
| M7404400002 | Male Plate |
| M7404400001 | Male Plate |