STALIF C-Ti
GUDID 00815101028613
Centinel Spine, Inc.
Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile| Primary Device ID | 00815101028613 |
| NIH Device Record Key | 9f4a7195-8c31-4d19-9e37-ab2e317c6ab0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STALIF C-Ti |
| Version Model Number | C128571-3Tc |
| Company DUNS | 949024850 |
| Company Name | Centinel 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815101028613 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133200
FDA Product Code
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-20 |
On-Brand Devices [STALIF C-Ti]
Trademark Results [STALIF C-Ti]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STALIF C-TI 88064523 5725943 Live/Registered |
Centinel Spine, LLC 2018-08-03 |
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