Construx – Mini Ti
15mm W X 12mm L, 10° LORDOTIC - 11mm H IMPLANT, STERILE
7manufacturers in China registered for this device type
112catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K211704 |
| Record published | 2026-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37-8107SP | In distribution | |
| 37-9309SP | In distribution | |
| 37-9306SP | In distribution | |
| 37-9112SP | In distribution | |
| 37-6012SP | In distribution | |
| 37-8006SP | In distribution | |
| 37-7105SP | In distribution | |
| 37-7108SP | In distribution | |
| 37-8109SP | In distribution | |
| 37-8108SP | In distribution | |
| 37-7211SP | In distribution | |
| 37-9111SP | In distribution | |
| 37-7309SP | In distribution | |
| 37-7011SP | In distribution | |
| 37-9210SP | In distribution | |
| 37-9312SP | In distribution | |
| 37-9311SP | In distribution | |
| 37-7311SP | In distribution | |
| 37-6108SP | In distribution | |
| 37-6208SP | In distribution | |
| 37-8212SP | In distribution | |
| 37-9109SP | In distribution | |
| 37-8007SP | In distribution | |
| 37-6107SP | In distribution | |
| 37-7206SP | In distribution | |
| 37-7310SP | In distribution | |
| 37-8306SP | In distribution | |
| 37-7107SP | In distribution | |
| 37-9108SP | In distribution | |
| 37-9008SP | In distribution | |
| 37-8110SP | In distribution | |
| 37-8310SP | In distribution | |
| 37-9006SP | In distribution | |
| 37-6011SP | In distribution | |
| 37-6211SP | In distribution | |
| 37-8209SP | In distribution | |
| 37-7110SP | In distribution | |
| 37-6111SP | In distribution | |
| 37-7109SP | In distribution | |
| 37-7112SP | In distribution | |
| 37-7209SP | In distribution | |
| 37-8309SP | In distribution | |
| 37-6010SP | In distribution | |
| 37-8111SP | In distribution | |
| 37-8015SP | In distribution | |
| 37-7306SP | In distribution | |
| 37-8206SP | In distribution | |
| 37-7212SP | In distribution | |
| 37-8312SP | In distribution | |
| 37-9209SP | In distribution | |
| 37-7005SP | In distribution | |
| 37-9005SP | In distribution | |
| 37-6308SP | In distribution | |
| 37-8008SP | In distribution | |
| 37-9110SP | In distribution | |
| 37-7210SP | In distribution | |
| 37-7009SP | In distribution | |
| 37-6312SP | In distribution | |
| 37-9308SP | In distribution | |
| 37-8211SP | In distribution | |
| 37-6212SP | In distribution | |
| 37-8208SP | In distribution | |
| 37-6006SP | In distribution | |
| 37-6112SP | In distribution | |
| 37-7012SP | In distribution | |
| 37-7307SP | In distribution | |
| 37-7007SP | In distribution | |
| 37-9307SP | In distribution | |
| 37-9009SP | In distribution | |
| 37-8012SP | In distribution | |
| 37-6309SP | In distribution | |
| 37-7308SP | In distribution | |
| 37-6206SP | In distribution | |
| 37-6307SP | In distribution | |
| 37-9106SP | In distribution | |
| 37-9310SP | In distribution | |
| 37-9012SP | In distribution | |
| 37-6009SP | In distribution | |
| 37-7008SP | In distribution | |
| 37-6106SP | In distribution | |
| 37-9212SP | In distribution | |
| 37-9007SP | In distribution | |
| 37-6110SP | In distribution | |
| 37-6209SP | In distribution | |
| 37-9105SP | In distribution | |
| 37-8112SP | In distribution | |
| 37-6005SP | In distribution | |
| 37-7208SP | In distribution | |
| 37-8311SP | In distribution | |
| 37-6008SP | In distribution | |
| 37-7312SP | In distribution | |
| 37-8105SP | In distribution | |
| 37-8005SP | In distribution | |
| 37-8307SP | In distribution | |
| 37-9206SP | In distribution | |
| 37-6310SP | In distribution | |
| 37-6306SP | In distribution | |
| 37-9208SP | In distribution | |
| 37-8011SP | In distribution | |
| 37-9211SP | In distribution | |
| 37-6007SP | In distribution | |
| 37-8009SP | In distribution | |
| 37-6210SP | In distribution | |
| 37-6105SP | In distribution | |
| 37-9107SP | In distribution | |
| 37-6311SP | In distribution | |
| 37-7006SP | In distribution | |
| 37-9207SP | In distribution | |
| 37-8308SP | In distribution | |
| 37-6207SP | In distribution | |
| 37-7111SP | In distribution | |
| 37-9011SP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Orthofix US LLC | UDI-DI | 2025-11-03 | Class III | Device Design | Labeling contains claims that are not consistently present. | 40956 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-11-03 | Class III | Device Design | Labeling contains claims that are not consistently present. | 61977 |
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.