MIDLINE II
GUDID 00815101021041
Centinel Spine, Inc.
Polymeric spinal fusion cage, sterile| Primary Device ID | 00815101021041 |
| NIH Device Record Key | 274f8d23-a15d-4f1a-ac68-1685d23c7120 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIDLINE II |
| Version Model Number | M421916 |
| Company DUNS | 949024850 |
| Company Name | Centinel Spine, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00815101021041 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133286
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 | 2016-12-21 |
On-Brand Devices [MIDLINE II]
Trademark Results [MIDLINE II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIDLINE II 87258345 5342887 Live/Registered |
CENTINEL SPINE, LLC 2016-12-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.