Omnia Medical TiBrid™-SA
TiBrid™ SA Self Drilling Variable Tack, 6.0 x 20mm
3manufacturers in China registered for this device type
14catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Omnia Medical, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-12 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 30 to 38 mm; length 15 to 25 mm; outer diameter 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17-0A-PLT2 | Height 34 mm | In distribution |
| 17-0A-PLT9 | Height 38 mm | In distribution |
| 17-0A-PLT6 | Height 32 mm | In distribution |
| 17-1A-6020 | Length 20 mm | In distribution |
| 17-0A-PLT0 | Height 30 mm | In distribution |
| 17-0A-PLT7 | Height 34 mm | In distribution |
| 17-1A-6025 | Length 25 mm | In distribution |
| 17-0A-PLT4 | Height 38 mm | In distribution |
| 17-0A-PLT8 | Height 36 mm | In distribution |
| 17-5A-PLS1 | In distribution | |
| 17-0A-PLT5 | Height 30 mm | In distribution |
| 17-0A-PLT3 | Height 36 mm | In distribution |
| 17-1A-6015 | Length 15 mm | In distribution |
| 17-0A-PLT1 | Height 32 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240623 | 2024-04-24 |
| K203207 | 2020-12-23 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-07-15 | Class II | Device Design | Failure of fusion system instruments in the field. | 15 units |
| 2024-07-15 | Class II | Device Design | Failure of fusion system instruments in the field. | 15 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.