BEE HA Cage
The BEE HA Cage is an anterior cervical interbody implant that supports fusion between vertebrae. It has a hollow chamber for bone graft and toothed upper and lower surfaces that help…
The BEE HA Cage is an anterior cervical interbody implant that supports fusion between vertebrae. It has a hollow chamber for bone graft and toothed upper and lower surfaces that help stabilize its position.
The cage is made from hydroxyapatite-enhanced PEEK with four titanium alloy pins for imaging visibility. A flat lower surface, domed upper surface and lordotic profile accommodate cervical anatomy, with multiple footprints and angles available.
Listed Item
BEE HA Cages were especially adapted to the local anatomy to secure the surgical outcome at the best. The caudal side is flat, the cranial side is domed and the implants formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The cage disposes of 4 pins on both bone facing surfaces. BEE HA implants are made of PEEK-OPTIMA HA ENHANCED and pins made out of titanium alloy (Ti6Al4V) according to ASTM F136. It is not allowed to use BEE HA implants in contact with components of other manufacturers.
Fusion Conditions
It is intended for skeletally mature patients at one or more contiguous levels from C2 to T1 after at least six weeks of nonoperative treatment. Autograft or specified allograft and supplemental cervical fixation are required.
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 | Ngmedical Gmbh, Germany |
|---|---|
| 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, Manufacturer |
| 510(k) | K203444 |
| Record published | 2022-08-11 |
| Record revised | 2026-02-25 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cervical 9×18 mm 4° | 9 x 18 mm 4° | In distribution |
| Cervical 5×16 mm 4° | 5 x 16 mm 4° | In distribution |
| Cervical 7×16 mm 12° | 7 x 16 mm 12° | In distribution |
| Cervical 9×18 mm 8° | 9 x 18 mm 8° | In distribution |
| Cervical 7×18 mm 4° | 7 x 18 mm 4° | In distribution |
| Cervical 7×16 mm 8° | 7 x 16 mm 8° | In distribution |
| Cervical 5×18 mm 8° | 5 x 18 mm 8° | In distribution |
| Cervical 6×18 mm 4° | 6 x 18 mm 4° | In distribution |
| Cervical 6×18 mm 12° | 6 x 18 mm 12° | In distribution |
| Cervical 6×16 mm 12° | 6 x 16 mm 12° | In distribution |
| Cervical 9×16 mm 4° | 9 x 16 mm 4° | In distribution |
| Cervical 9×16 mm 12° | 9 x 16 mm 12° | In distribution |
| Cervical 7×16 mm 4° | 7 x 16 mm 4° | In distribution |
| Cervical 7×18 mm 12° | 7 x 18 mm 12° | In distribution |
| Cervical 8×18 mm 4° | 8 x 18 mm 4° | In distribution |
| Cervical 8×16 mm 4° | 8 x 16 mm 4° | In distribution |
| Cervical 9×18 mm 12° | 9 x 18 mm 12° | In distribution |
| Cervical 5×18 mm 12° | 5 x 18 mm 12° | In distribution |
| Cervical 6×16 mm 4° | 6 x 16 mm 4° | In distribution |
| Cervical 5×18 mm 4° | 5 x 18 mm 4° | In distribution |
| Cervical 10×18 mm 12° | 10 x 18 mm 12° | In distribution |
| Cervical 6×18 mm 8° | 6 x 18 mm 8° | In distribution |
| Cervical 8×18 mm 12° | 8 x 18 mm 12° | In distribution |
| Cervical 5×16 mm 8° | 5 x 16 mm 8° | In distribution |
| Cervical 8×16 mm 12° | 8 x 16 mm 12° | In distribution |
| Cervical 6×16 mm 8° | 6 x 16 mm 8° | In distribution |
| Cervical 7×18 mm 8° | 7 x 18 mm 8° | In distribution |
| Cervical 9×16 mm 8° | 9 x 16 mm 8° | In distribution |
| Cervical 8×18 mm 8° | 8 x 18 mm 8° | In distribution |
| Cervical 8×16 mm 8° | 8 x 16 mm 8° | 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 |
|---|---|
| K250560 | 2025-11-21 |
| K231371 | 2024-01-12 |
| K203444 | 2021-03-18 |
| K200429 | 2021-01-29 |
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.