Nest-C Interbody System
Nest-C is a cervical interbody fusion cage made by additive manufacturing from titanium alloy powder. Solid and porous structures are built together. A central hollow window and internal…
Nest-C is a cervical interbody fusion cage made by additive manufacturing from titanium alloy powder. Solid and porous structures are built together. A central hollow window and internal pores accommodate bone graft, while serrations on the upper and lower surfaces assist fixation.
The system is indicated for skeletally mature patients with degenerative disc disease at one or more contiguous levels from C2 to T1 after six weeks of nonoperative treatment. Degeneration is associated with discogenic neck pain confirmed by patient history and imaging.
Graft and Supplemental Fixation
The cage is used with autogenous bone graft or cancellous or corticocancellous allogeneic graft. It requires a supplemental fixation system cleared for the cervical spine. Multiple footprints, heights and lordotic angles allow selection for the patient’s anatomy; the cage is one part of the fusion construct.
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 | Paonan Biotech Co., Ltd., Taiwan |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K220261 |
| Record published | 2026-05-08 |
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 |
| Sizes | Width 14 to 16 mm; length 12 to 14 mm; height 5 to 9 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21001114120902 | Width 14 mm | In distribution |
| 21001114120602 | Width 14 mm | In distribution |
| 21001114120802 | Width 14 mm | In distribution |
| 21001114120702 | Width 14 mm | In distribution |
| 21001116140902 | Width 16 mm | In distribution |
| 21001116140802 | Width 16 mm | In distribution |
| 21001116140502 | Width 16 mm | In distribution |
| 21001116140702 | Width 16 mm | In distribution |
| 21001116140602 | Width 16 mm | In distribution |
| 21001114120502 | Width 14 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220261 | 2023-04-24 |
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.