| Primary Device ID | 00810017912629 |
| NIH Device Record Key | b558a351-2f65-4dec-a067-bec96587246c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trial Head 12x15x5 9 deg. |
| Version Model Number | CI-TH2595 |
| Catalog Number | CI-TH2595 |
| Company DUNS | 085718404 |
| Company Name | ELEVATION 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810017912629 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-08 |
| Device Publish Date | 2019-12-31 |
| 00810017915262 - Screw Handle | 2025-09-22 Screw Handle (Ratcheting) |
| 00810017915279 - Spike Implants | 2025-09-22 Saber-C 14mm Spikes (No Carriage) |
| 00810017914777 - Double Ended Rasp/Trial 12x15x5, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x5, 6° |
| 00810017914784 - Double Ended Rasp/Trial 12x15x6, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x6, 6° |
| 00810017914791 - Double Ended Rasp/Trial 12x15x7, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x7, 6° |
| 00810017914807 - Double Ended Rasp/Trial 12x15x8, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x8, 6° |
| 00810017914814 - Double Ended Rasp/Trial 12x15x9, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x9, 6° |
| 00810017914821 - Double Ended Rasp/Trial 14x17x5, 6° | 2025-04-07 Double Ended Rasp/Trial 14x17x5, 6° |