MIDLINE II-Ti M391508c-35
GUDID 00843193111623
Centinel Spine, Inc.
Polymeric spinal fusion cage, sterile| Primary Device ID | 00843193111623 |
| NIH Device Record Key | cdcfe3e1-ca11-45b8-8b7d-6db6d078ca16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIDLINE II-Ti |
| Version Model Number | M391508c-35 |
| Catalog Number | M391508c-35 |
| 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 |
Customer Support Contacts
| Phone | 484-887-8810 |
| complaints@centinelspine.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843193111623 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-19 |
| Device Publish Date | 2018-06-18 |
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 |
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