| Primary Device ID | 00810017912674 |
| NIH Device Record Key | 4771cef0-cb59-46af-b4d1-828fe7f06324 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trial Head 12x15x10 9 deg. |
| Version Model Number | CI-TH2591 |
| Catalog Number | CI-TH2591 |
| 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 |
| Phone | 844-415-0226 |
| info@elevationspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810017912674 [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 | 2020-01-13 |
| Device Publish Date | 2020-01-03 |
| 00810017913411 - SABER-C RASP | 2024-01-29 Saber-C Rasp, 12x15x5, 6 deg. |
| 00810017913428 - SABER-C RASP | 2024-01-29 Saber-C Rasp, 14x17x5, 6 deg |
| 00810017913497 - SABER-C BASE WITH INSERT TRAY | 2024-01-29 SABER-C BASE WITH INSERT TRAY |
| 00810017913435 - Carriage 5-6mm | 2024-01-26 Carriage 5-6mm |
| 00810017913442 - Carriage 7mm | 2024-01-26 Carriage 7mm |
| 00810017913459 - Carriage 8mm | 2024-01-26 Carriage 8mm |
| 00810017913466 - Carriage 9mm | 2024-01-26 Carriage 9mm |
| 00810017913473 - Carriage 10mm | 2024-01-26 Carriage 10mm |