| Primary Device ID | 00857360007190 |
| NIH Device Record Key | ffa73873-4f70-42f5-96c7-e4d431f8a1aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FCD-2 IMPLANT SYSTEM |
| Version Model Number | 9063 |
| Catalog Number | 9063-00 |
| Company DUNS | 080963983 |
| Company Name | DECIMA SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |