Screw Driver CI-DRIVER-SC
GUDID 00810017912315
Screw Driver
ELEVATION SPINE, INC.
Intervertebral-body internal spinal fixation system| Primary Device ID | 00810017912315 |
| NIH Device Record Key | 312a7a5d-4a13-4dee-a19d-33f880d6a4fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Screw Driver |
| Version Model Number | CI-DRIVER-SC |
| Catalog Number | CI-DRIVER-SC |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810017912315 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190885
FDA Product Code
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-07 |
| Device Publish Date | 2019-12-30 |
Devices Manufactured by ELEVATION SPINE, INC.
| 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° |
| 00810017914838 - Double Ended Rasp/Trial 14x17x6, 6° | 2025-04-07 Double Ended Rasp/Trial 14x17x6, 6° |
| 00810017914845 - Double Ended Rasp/Trial 14x17x7, 6° | 2025-04-07 Double Ended Rasp/Trial 14x17x7, 6° |
Trademark Results [Screw Driver]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCREW DRIVER 78439150 not registered Dead/Abandoned |
Dynacraft Golf Products, Inc. 2004-06-22 |
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