BEE HA
BEE HA is a cervical interbody fusion cage made from hydroxyapatite-enhanced PEEK. A hollow chamber holds bone graft between adjacent vertebrae, and supplemental fixation is used with the…
BEE HA is a cervical interbody fusion cage made from hydroxyapatite-enhanced PEEK. A hollow chamber holds bone graft between adjacent vertebrae, and supplemental fixation is used with the cage.
The cage has a flat lower surface, domed upper surface and a shape that tapers from front to back. Teeth on the bone-facing surfaces engage the endplates, while four titanium alloy pins provide radiographic visibility.
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 implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic formand is available in 4°, 8° and 12° lordosis. 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_ELI) according to ASTMF136. It is not allowed to use BEE® HA implants in contact with components of other manufacturers with the exception of autogenous and/or allogeneic bone graft comprised of cancellous and/or coricocancellous bone graft.
Graft and Sizes
Different footprints and lordotic angles accommodate cervical anatomy. The cage is used with autogenous or allogenic cancellous or corticocancellous bone graft for specified fusion applications from C2 to T1. The hydroxyapatite is incorporated into the PEEK material, with the titanium pins forming separate components.
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 | 2026-04-21 |
| Record revised | 2026-04-29 (version 3) |
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 10x14mm 4°S | In distribution | |
| Cervical 6x14mm 4°S | In distribution | |
| Cervical 4x14mm 8°S | In distribution | |
| Cervical 7x16mm 12°S | In distribution | |
| Cervical 5×16 mm 12° | 5 x 16 mm 12° | In distribution |
| Cervical 4x16mm 4°S | In distribution | |
| Cervical 8x16mm 4°S | In distribution | |
| Cervical 10x14mm 12°S | In distribution | |
| Cervical 5x14mm 8°S | In distribution | |
| Cervical 10×16 mm 8° | 10 x 16 mm 8° | In distribution |
| Cervical 10×18 mm 8° | 10 x 18 mm 8° | In distribution |
| Cervical 4x16mm 12°S | In distribution | |
| Cervical 7x14mm 8°S | In distribution | |
| Cervical 10x16mm 12°S | In distribution | |
| Cervical 9x14mm 8°S | In distribution | |
| Cervical 7x14mm 4°S | In distribution | |
| Cervical 5x16mm 8°S | In distribution | |
| Cervical 7x14mm 12°S | In distribution | |
| Cervical 7x16mm 4°S | In distribution | |
| Cervical 10x16mm 8°S | In distribution | |
| Cervical 8x16mm 8°S | In distribution | |
| Cervical 10x16mm 4° | In distribution | |
| Cervical 4x14mm 12°S | In distribution | |
| Cervical 4×16 mm 4° | 4 x 16 mm 4° | In distribution |
| Cervical 10x14mm 8°S | In distribution | |
| Cervical 5x16mm 12°S | In distribution | |
| Cervical 8x14mm 4°S | In distribution | |
| Cervical 4×18 mm 8° | 4 x 18 mm 8° | In distribution |
| Cervical 5x16mm 4°S | In distribution | |
| Cervical 10×18 mm 4° | 10 x 18 mm 4° | In distribution |
| Cervical 9x16mm 8°S | In distribution | |
| Cervical 4x14mm 4°S | In distribution | |
| Cervical 6x16mm 8°S | In distribution | |
| Cervical 9x14mm 4°S | In distribution | |
| Cervical 10×16 mm 4° | 10 x 16 mm 4° | In distribution |
| Cervical 7x16mm 8°S | In distribution | |
| Cervical 8x16mm 12°S | In distribution | |
| Cervical 5x14mm 12°S | In distribution | |
| Cervical 4×18 mm 4° | 4 x 18 mm 4° | In distribution |
| Cervical 8x14mm 12°S | In distribution | |
| Cervical 9x14mm 12°S | In distribution | |
| Cervical 4×18 mm 12° | 4 x 18 mm 12° | In distribution |
| Cervical 8x14mm 8°S | In distribution | |
| Cervical 5x14mm 4°S | In distribution | |
| Cervical 9x16mm 4°S | In distribution | |
| Cervical 4x16mm 8°S | In distribution | |
| Cervical 6x16mm 4°S | In distribution | |
| Cervical 6x14mm 12°S | In distribution | |
| Cervical 6x14mm 8°S | In distribution | |
| Cervical 4×16 mm 12° | 4 x 16 mm 12° | In distribution |
| Cervical 4×16 mm 8° | 4 x 16 mm 8° | In distribution |
| Cervical 6x16mm 12°S | In distribution | |
| Cervical 9x14mm 12°S | In distribution | |
| Cervical 10x16mm 4°S | 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.