| Primary Device ID | B521108826100810 |
| NIH Device Record Key | 3c8f7e17-cce2-4ecd-a617-53e2abd377ef |
| Commercial Distribution Discontinuation | 2019-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ECHO TiNano PLIF |
| Version Model Number | 108026100810 |
| Catalog Number | 108826100810 |
| Company DUNS | 079119091 |
| Company Name | AURORA SPINE, INC. |
| 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 | true |
| 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 | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx |
| Height | 10 Millimeter |
| Angle | 8 degree |
| Width | 10 Millimeter |
| Length | 26 Millimeter |
| Height | 10 Millimeter |
| Angle | 8 degree |
| Width | 10 Millimeter |
| Length | 26 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B521108826100810 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-29 |
| Device Publish Date | 2017-02-02 |
| B521108826100810 | ECHO TiNano PLIF 26mm X 10mm X 8 X 10mm |
| B521108824080807 | ECHO TiNano PLIF 24mm X 8mm X 8 X 7mm |
| B521108822080812 | ECHO TiNano PLIF 22mm X 8mm X 8 X 12mm |
| B521108822080810 | ECHO TiNano PLIF 22mm X 8mm X 8 X 10mm, CAGE, PEEK-TICP |