MIDLINE II-Ti
GUDID 00815101021744
Centinel Spine, Inc.
Metal-polymer composite spinal interbody fusion cage| Primary Device ID | 00815101021744 |
| NIH Device Record Key | 8a6d2bab-e3c2-40aa-852a-6f8ec608e257 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIDLINE II-Ti |
| Version Model Number | M391316c |
| 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 | 00815101021744 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141942
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 | 5 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-12-28 |
On-Brand Devices [MIDLINE II-Ti]
Trademark Results [MIDLINE II-Ti]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIDLINE II-TI 88064543 5823588 Live/Registered |
Centinel Spine, LLC 2018-08-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.