| Primary Device ID | 00810017915262 |
| NIH Device Record Key | 7d2a8ab4-0b4b-43fa-be43-2d370a68507b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Screw Handle |
| Version Model Number | CI-HANDLE-SR |
| 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 | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com | |
| Phone | 844-415-0226 |
| info@elevationspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810017915262 [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 | 2025-09-22 |
| Device Publish Date | 2025-09-12 |
| 00810017912322 | Screw Handle |
| 00810017915262 | Screw Handle (Ratcheting) |