TiBrid™-SA
GUDID 00843511111816
TiBrid™-SA SCREW COVER, 12mm
OMNIA MEDICAL, LLC
Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage| Primary Device ID | 00843511111816 |
| NIH Device Record Key | 76cd7e8c-ccd8-401a-83f1-43b28364288f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiBrid™-SA |
| Version Model Number | 17-0A-CVR2 |
| Company DUNS | 079467378 |
| Company Name | OMNIA MEDICAL, LLC |
| 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 | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com |
Device Dimensions
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511111816 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203207
FDA Product Code
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
[00843511111816]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-27 |
| Device Publish Date | 2024-03-19 |
On-Brand Devices [TiBrid™-SA]
| 00843511113131 | TiBrid™-SA SCREW COVER, 18mm |
| 00843511113124 | TiBrid™-SA SCREW COVER, 16mm |
| 00843511113117 | TiBrid™-SA SCREW COVER, 14mm |
| 00843511111816 | TiBrid™-SA SCREW COVER, 12mm |
| 00843511111809 | TiBrid™-SA SCREW COVER, 10mm |
Trademark Results [TiBrid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIBRID 87649034 5846124 Live/Registered |
Omnia Medical 2017-10-17 |
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