TiBrid™-SA
TiBrid-SA is a standalone lumbar interbody fusion system with integrated fixation. Its spacers use PEEK-OPTIMA HA Enhanced material, titanium-alloy components and tantalum for radiographic…
TiBrid-SA is a standalone lumbar interbody fusion system with integrated fixation. Its spacers use PEEK-OPTIMA HA Enhanced material, titanium-alloy components and tantalum for radiographic visualization.
The implant has a hollow centre for bone graft and anti-migration features. Different footprints, heights and angles accommodate the treated disc space.
Listed Item
TiBrid-SA Self-Drilling Variable Screw, 15 to 35mm length, Caddy
Integrated Screws and Graft
The system must be used with the internal bone screws supplied. It accepts autogenous and/or allogeneic cancellous or corticocancellous bone graft. The lumbar indication covers one or two adjacent levels from L2 to S1 in skeletally mature patients, with the integrated fixation forming part of the standalone construct.
3manufacturers in China registered for this device type
140catalogue 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 |
| 510(k) | K203207 |
| Record published | 2023-01-31 |
| Record revised | 2025-07-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 15 to 35 mm; width 32 to 40 mm; height 10 to 18 mm; angle 8 to 20 °; outer diameter 5.5 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17-0A-6035-TV | Outer Diameter 6.0 mm | In distribution |
| 17-0A-402912-16 | Width 40 mm | In distribution |
| 17-0A-5535-TF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-6030-TV | Outer Diameter 6.0 mm | In distribution |
| 17-0A-322516-20 | Width 32 mm | In distribution |
| 17-0A-6035-DF | Outer Diameter 6.0 mm | In distribution |
| 17-5A-INS3 | In distribution | |
| 17-5A-INS2 | In distribution | |
| 17-5A-DRL1 | In distribution | |
| 17-0A-402918-16 | Width 40 mm | In distribution |
| 17-0A-402916-16 | Width 40 mm | In distribution |
| 17-5A-DRV5 | In distribution | |
| 17-0A-322518-08 | Width 32 mm | In distribution |
| 17-0A-322518-20 | Width 32 mm | In distribution |
| 17-0A-5515-DF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-322512-16 | Width 32 mm | In distribution |
| 17-0A-362718-16 | Width 36 mm | In distribution |
| 17-0A-5525-TV | Outer Diameter 5.5 mm | In distribution |
| 17-0A-402914-12 | Width 40 mm | In distribution |
| 17-0A-362712-20 | Width 36 mm | In distribution |
| 17-0A-CVR6 | Outer Diameter 16 mm | In distribution |
| 17-5A-DRL2 | In distribution | |
| 17-0A-5520-TF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-362718-08 | Width 36 mm | In distribution |
| 17-5A-PDG1 | In distribution | |
| 17-0A-5530-DF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-402910-08 | Width 40 mm | In distribution |
| 17-0A-6035-DV | Outer Diameter 6.0 mm | In distribution |
| 17-0A-6030-DV | Outer Diameter 6.0 mm | In distribution |
| 17-5A-DV60 | In distribution | |
| 17-0A-322510-08 | Width 32 mm | In distribution |
| 17-0A-5515-TV | Outer Diameter 5.5 mm | In distribution |
| 17-8A-CAD4 | In distribution | |
| 17-0A-6030-DF | Outer Diameter 6.0 mm | In distribution |
| 17-5A-DV30 | In distribution | |
| 17-5A-AWL5 | In distribution | |
| 17-0A-362716-12 | Width 36 mm | In distribution |
| 17-0A-322512-08 | Width 32 mm | In distribution |
| 17-0A-322518-16 | Width 32 mm | In distribution |
| 17-0A-322516-08 | Width 32 mm | In distribution |
| 17-0A-362712-16 | Width 36 mm | In distribution |
| 17-5A-DRV3 | In distribution | |
| 17-0A-402918-20 | Length 29 mm | In distribution |
| 17-0A-322512-12 | Width 32 mm | In distribution |
| 17-5A-DL30 | In distribution | |
| 17-0A-402916-08 | Width 40 mm | In distribution |
| 17-8A-CAD2 | In distribution | |
| 17-0A-362714-12 | Width 36 mm | In distribution |
| 17-0A-5520-DF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-362712-08 | Width 36 mm | In distribution |
| 17-0A-402910-16 | Width 40 mm | In distribution |
| 17-0A-402918-12 | Width 40 mm | In distribution |
| 17-0A-6015-TF | Outer Diameter 6.0 mm | In distribution |
| 17-8A-TRY3 | In distribution | |
| 17-0A-CVR2 | Outer Diameter 12 mm | In distribution |
| 17-0A-362714-08 | Width 36 mm | In distribution |
| 17-5A-DL60 | In distribution | |
| 17-0A-362710-12 | Width 36 mm | In distribution |
| 17-0A-322516-16 | Width 32 mm | In distribution |
| 17-0A-362716-20 | Width 36 mm | In distribution |
| 17-0A-5515-DV | Outer Diameter 5.5 mm | In distribution |
| 17-0A-402912-20 | Width 40 mm | In distribution |
| 17-8A-CAD5 | In distribution | |
| 17-0A-5520-TV | Outer Diameter 5.5 mm | In distribution |
| 17-0A-322510-16 | Width 32 mm | In distribution |
| 17-0A-322514-16 | Width 32 mm | In distribution |
| 17-0A-5525-DV | Outer Diameter 5.5 mm | In distribution |
| 17-5A-INS1-D | In distribution | |
| 17-0A-5530-DV | Outer Diameter 5.5 mm | In distribution |
| 17-5A-BTD1 | In distribution | |
| 17-0A-6020-DV | Outer Diameter 6.0 mm | In distribution |
| 17-0A-322510-12 | Width 32 mm | In distribution |
| 17-0A-362714-20 | Width 36 mm | In distribution |
| 17-0A-CVR4 | Outer Diameter 14 mm | In distribution |
| 17-8A-TRY2 | In distribution | |
| 17-0A-5535-TV | Outer Diameter 5.5 mm | In distribution |
| 17-0A-CVR8 | Outer Diameter 18 mm | In distribution |
| 17-0A-6020-TF | Outer Diameter 6.0 mm | In distribution |
| 17-0A-5535-DV | Outer Diameter 5.5 mm | In distribution |
| 17-0A-362710-08 | Width 36 mm | In distribution |
| 17-5A-AWL3 | In distribution | |
| 17-5A-AWL2 | In distribution | |
| 17-0A-CVR0 | Outer Diameter 10 mm | In distribution |
| 17-0A-6025-TV | Outer Diameter 6.0 mm | In distribution |
| 17-5A-AWL1 | In distribution | |
| 17-0A-6015-TV | Outer Diameter 6.0 mm | In distribution |
| 17-8A-CAD1 | In distribution | |
| 17-5A-AWL2-E | In distribution | |
| 17-0A-402910-12 | Width 40 mm | In distribution |
| 17-0A-362712-12 | Width 36 mm | In distribution |
| 17-0A-5530-TV | Outer Diameter 5.5 mm | In distribution |
| 17-0A-402914-08 | Width 40 mm | In distribution |
| 17-0A-322514-12 | Width 32 mm | In distribution |
| 17-5A-INS1 | In distribution | |
| 17-0A-362716-16 | Width 36 mm | In distribution |
| 17-0A-362716-08 | Width 36 mm | In distribution |
| 17-0A-6015-DV | Outer Diameter 6.0 mm | In distribution |
| 17-0A-322516-12 | Width 32 mm | In distribution |
| 17-0A-6020-TV | Outer Diameter 6.0 mm | In distribution |
| 17-0A-5535-DF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-5530-TF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-402914-16 | Width 40 mm | In distribution |
| 17-0A-5525-DF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-402916-12 | Width 40 mm | In distribution |
| 17-5A-DRV4 | In distribution | |
| 17-0A-362718-12 | Width 36 mm | In distribution |
| 17-8A-CAD6 | In distribution | |
| 17-0A-6025-DF | Outer Diameter 6.0 mm | In distribution |
| 17-0A-6030-TF | Outer Diameter 6.0 mm | In distribution |
| 17-5A-AWL6 | In distribution | |
| 17-0A-6025-TF | Outer Diameter 6.0 mm | In distribution |
| 17-8A-TRY1 | In distribution | |
| 17-5A-IDG1 | In distribution | |
| 17-0A-402912-08 | Width 40 mm | In distribution |
| 17-0A-322514-08 | Width 32 mm | In distribution |
| 17-0A-362710-16 | Width 36 mm | In distribution |
| 17-5A-DRV1 | In distribution | |
| 17-0A-6035-TF | Outer Diameter 6.0 mm | In distribution |
| 17-0A-402916-20 | Angle 20 ° | In distribution |
| 17-0A-5525-TF | Outer Diameter 5.5 mm | In distribution |
| 17-5A-DRV2 | In distribution | |
| 17-0A-362718-20 | Width 36 mm | In distribution |
| 17-8A-CAD3 | In distribution | |
| 17-5A-AWL4 | In distribution | |
| 17-0A-5520-DV | Outer Diameter 5.5 mm | In distribution |
| 17-0A-6020-DF | Outer Diameter 6.0 mm | In distribution |
| 17-5A-RMV1 | In distribution | |
| 17-0A-5515-TF | Outer Diameter 5.5 mm | In distribution |
| 17-0A-402914-20 | Width 40 mm | In distribution |
| 17-0A-322518-12 | Width 32 mm | In distribution |
| 17-0A-322514-20 | Width 32 mm | In distribution |
| 17-0A-6025-DV | Outer Diameter 6.0 mm | In distribution |
| 17-0A-322512-20 | Width 32 mm | In distribution |
| 17-0A-322510-20 | Width 32 mm | In distribution |
| 17-5A-DL45 | In distribution | |
| 17-0A-402912-12 | Width 40 mm | In distribution |
| 17-0A-402918-08 | Width 40 mm | In distribution |
| 17-5A-DV45 | In distribution | |
| 17-0A-362714-16 | Width 36 mm | In distribution |
| 17-0A-6015-DF | Outer Diameter 6.0 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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Omnia Medical | 510(k) number | 2024-07-15 | Class II | Device Design | Failure of fusion system instruments in the field. | 15 units |
| Omnia Medical | 510(k) number | 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.