Manta Ray TDF
Manta Ray TDF is a cervical interbody spacer with lateral wings that engage the uncovertebral joints as well as the central disc space. It holds bone graft between adjacent vertebrae during…
Manta Ray TDF is a cervical interbody spacer with lateral wings that engage the uncovertebral joints as well as the central disc space. It holds bone graft between adjacent vertebrae during fusion and is used with supplemental fixation.
The spacer has a PEEK body, tantalum markers for radiographic visibility and a one-micron layer of commercially pure titanium called NanoMetalene. This surface layer has microscopic roughness and nanoscale features.
Listed Item
Manta Ray TDF Spacer, 20x15x11mm, 10 Deg, Strl Asm
Graft and Configurations
A central window receives the patient’s own bone graft or allogenic bone graft. Different footprints, heights and lordotic angles accommodate the treated anatomy. The spacer is supplied sterile, while its placement instruments are organized in trays for steam sterilization. Its intended cervical fusion applications extend from C3 to T1 in skeletally mature patients.
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) | K220296 |
| Record published | 2025-12-19 |
| Record revised | 2025-10-24 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| US1-201009 | In distribution | |
| US1-401006 | In distribution | |
| US1-300712 | In distribution | |
| US1-300711 | In distribution | |
| US1-200712 | In distribution | |
| US1-300706 | In distribution | |
| US1-200707 | In distribution | |
| US1-401011 | In distribution | |
| US1-300707 | In distribution | |
| US1-301010 | In distribution | |
| US1-301008 | In distribution | |
| US1-200709 | In distribution | |
| US1-301011 | In distribution | |
| US1-200705 | In distribution | |
| US1-301012 | In distribution | |
| US1-201007 | In distribution | |
| US1-400707 | In distribution | |
| US1-201011 | In distribution | |
| US1-301006 | In distribution | |
| US1-300709 | In distribution | |
| US1-400712 | In distribution | |
| US1-401509 | In distribution | |
| US1-400706 | In distribution | |
| US1-201010 | In distribution | |
| US1-200706 | In distribution | |
| US1-401010 | In distribution | |
| US1-201006 | In distribution | |
| US1-200708 | In distribution | |
| US1-301009 | In distribution | |
| US1-401012 | In distribution | |
| US1-300708 | In distribution | |
| US1-401508 | In distribution | |
| US1-401511 | In distribution | |
| US1-400708 | In distribution | |
| US1-401512 | In distribution | |
| US1-400710 | In distribution | |
| US1-201008 | In distribution | |
| US1-301007 | In distribution | |
| US1-400705 | In distribution | |
| US1-400711 | In distribution | |
| US3-000210 | In distribution | |
| US1-300705 | In distribution | |
| US1-400709 | In distribution | |
| US1-300710 | In distribution | |
| US1-401007 | In distribution | |
| US3-000207 | In distribution | |
| US1-200711 | In distribution | |
| US1-401009 | In distribution | |
| US1-401008 | In distribution | |
| US1-201012 | In distribution | |
| US1-200710 | In distribution | |
| US1-401510 | 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.