STALIF L
GUDID 00815101022086
Centinel Spine, Inc.
Polymeric spinal fusion cage, sterile| Primary Device ID | 00815101022086 |
| NIH Device Record Key | 97884026-1c83-46fd-b778-ef500c0cd84b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STALIF L |
| Version Model Number | STL5514-10 |
| 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 | 00815101022086 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130461
FDA Product Code
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
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 | 2017-01-23 |
On-Brand Devices [STALIF L]
Trademark Results [STALIF L]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STALIF L 88064515 5725942 Live/Registered |
Centinel Spine, LLC 2018-08-03 |
 STALIF L 76698920 not registered Dead/Abandoned |
Surgicraft Limited 2009-08-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.