| Primary Device ID | 00814216023650 |
| NIH Device Record Key | 075163d6-d032-42de-bb58-08598e453c90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FortiCore PLIF |
| Version Model Number | 10499-0001 |
| Catalog Number | 10499-0001 |
| Company DUNS | 079898044 |
| Company Name | NANOVIS 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 | 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 |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814216023650 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
[00814216023650]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-04-22 |
| 00814216023681 | FortiCore® PLIF Trial (7x9.5x22,6°) |
| 00814216023674 | PLIF FortiCore Inserter2 - 90 degree handle |
| 00814216023650 | PLIF Inserter - 90 degree handle |