Shoreline RT
Shoreline RT is a cervical interbody spacer with NanoMetalene titanium bonding and a central channel for bone graft. It is offered in different footprints and heights. The spacer can be…
Shoreline RT is a cervical interbody spacer with NanoMetalene titanium bonding and a central channel for bone graft. It is offered in different footprints and heights. The spacer can be used with supplemental fixation or as a standalone construct with Shoreline ACS screws and a locking cover.
For standalone use, treatment is limited to one level from C2 to T1. With supplemental fixation, the indicated range is one or two levels from C3 to C7. Two-level use always requires supplemental fixation. Patients must be skeletally mature with cervical degenerative disc disease.
Listed Item
Interbody, 18x15x11mm, 15 Degree, RT
Graft and Prior Treatment
At least six weeks of nonoperative treatment is expected before implantation. The spacer is filled with autograft or cancellous, cortical or corticocancellous allogeneic bone graft. The screw fixation and locking cover are required parts of the standalone configuration rather than optional substitutes for its fixation.
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 | Seaspine Orthopedics Corporation, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K183083 |
| Record published | 2021-03-17 |
| Record revised | 2025-10-24 (version 4) |
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 |
|---|---|---|
| 85-5909 | In distribution | |
| 85-5811 | In distribution | |
| 85-6307 | In distribution | |
| 85-5806 | In distribution | |
| 85-6611 | In distribution | |
| 85-6406 | In distribution | |
| 85-6310 | In distribution | |
| 85-6511 | In distribution | |
| 85-6707 | In distribution | |
| 85-6105 | In distribution | |
| 85-6711 | In distribution | |
| 85-6007 | In distribution | |
| 85-6409 | In distribution | |
| 85-6209 | In distribution | |
| 85-6111 | In distribution | |
| 85-6312 | In distribution | |
| 85-5906 | In distribution | |
| 85-6507 | In distribution | |
| 85-6109 | In distribution | |
| 85-6212 | In distribution | |
| 85-5911 | In distribution | |
| 85-6207 | In distribution | |
| 85-6807 | In distribution | |
| 85-6712 | In distribution | |
| 85-6309 | In distribution | |
| 85-6709 | In distribution | |
| 85-6810 | In distribution | |
| 85-6608 | In distribution | |
| 85-6806 | In distribution | |
| 85-5805 | In distribution | |
| 85-6812 | In distribution | |
| 85-6509 | In distribution | |
| 85-6705 | In distribution | |
| 85-6112 | In distribution | |
| 85-6411 | In distribution | |
| 85-5910 | In distribution | |
| 85-5912 | 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 |
|---|---|
| K220296 | 2023-02-03 |
| K183083 | 2019-02-14 |
| K172926 | 2017-12-21 |
| K171046 | 2017-07-07 |
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.