BEE Plif Cage
BEE Plif Cage is a titanium alloy lumbar interbody fusion implant made by additive manufacturing. It has rough upper and lower surfaces and is offered in different footprints, heights and…
BEE Plif Cage is a titanium alloy lumbar interbody fusion implant made by additive manufacturing. It has rough upper and lower surfaces and is offered in different footprints, heights and lordotic angles to accommodate vertebral anatomy.
The cage is intended for skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2 to S1 after six months of nonoperative treatment. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis.
Listed Item
BEE®PLIF cages have been specially adapted to suit the local anatomy to ensure the operative outcome to the greatest extent possible. BEE®PLIF cages are made of titanium alloy in accordance with ASTM F3001 and are produced in an additive manufacturing process. The implants are available in various heights, lengths and lordosis angles. The cranial and caudal side of the implant is rough to achieve a good degree of anchoring of the implant.
Implantation Requirements
Placement may use an open or minimally invasive posterior approach. The cage requires bone graft and supplemental fixation for lumbar use; the indications include autogenous or allogeneic cancellous or corticocancellous graft. Each implant is supplied sterile after gamma irradiation and is intended for single use.
14manufacturers in China registered for this device type
135catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Ngmedical Gmbh, Germany |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K211413 |
| Record published | 2022-08-08 |
| Record revised | 2026-02-25 (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 -5 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9 x 36 mm 0° | 9 x 36 mm 0° | In distribution |
| 12 x 30 mm 4° | 12 x 30 mm 4° | In distribution |
| 11 x 24 mm 8° | 11 x 24 mm 8° | In distribution |
| 12 x 30 mm 8° | 12 x 30 mm 8° | In distribution |
| 16 x 30 mm 18° | 16 x 30 mm 18° | In distribution |
| 9 x 36 mm 18° | 9 x 36 mm 18° | In distribution |
| 10 x 30 mm 4° | 10 x 30 mm 4° | In distribution |
| 15 x 24 mm 4° | 15 x 24 mm 4° | In distribution |
| 14 x 36 mm 0° | 14 x 36 mm 0° | In distribution |
| 11 x 36 mm 18° | 11 x 36 mm 18° | In distribution |
| 7 x 30 mm 4° | 7 x 30 mm 4° | In distribution |
| 10 x 36 mm 0° | 10 x 36 mm 0° | In distribution |
| 12 x 24 mm 4° | 12 x 24 mm 4° | In distribution |
| 10 x 36 mm 12° | 10 x 36 mm 12° | In distribution |
| 15 x 24 mm 12° | 15 x 24 mm 12° | In distribution |
| 12 x 24 mm 0° | 12 x 24 mm 0° | In distribution |
| 15 x 36 mm 8° | 15 x 36 mm 8° | In distribution |
| 14 x 36 mm 8° | 14 x 36 mm 8° | In distribution |
| 9 x 30 mm 8° | 9 x 30 mm 8° | In distribution |
| 8 x 30 mm 0° | 8 x 30 mm 0° | In distribution |
| 10 x 24 mm 18° | 10 x 24 mm 18° | In distribution |
| 13 x 36 mm 0° | 13 x 36 mm 0° | In distribution |
| 11 x 36 mm 0° | 11 x 36 mm 0° | In distribution |
| 11 x 30 mm 18° | 11 x 30 mm 18° | In distribution |
| 13 x 30 mm 4° | 13 x 30 mm 4° | In distribution |
| 13 x 24 mm 0° | 13 x 24 mm 0° | In distribution |
| 14 x 24 mm 8° | 14 x 24 mm 8° | In distribution |
| 8 x 24 mm 8° | 8 x 24 mm 8° | In distribution |
| 11 x 30 mm 4° | 11 x 30 mm 4° | In distribution |
| 8 x 36 mm 4° | 8 x 36 mm 4° | In distribution |
| 9 x 30 mm 12° | 9 x 30 mm 12° | In distribution |
| 10 x 36 mm 4° | 10 x 36 mm 4° | In distribution |
| 9 x 30 mm 4° | 9 x 30 mm 4° | In distribution |
| 14 x 30 mm 18° | 14 x 30 mm 18° | In distribution |
| 14 x 36 mm 12° | 14 x 36 mm 12° | In distribution |
| 12 x 30 mm 12° | 12 x 30 mm 12° | In distribution |
| 8 x 36 mm 0° | 8 x 36 mm 0° | In distribution |
| 11 x 24 mm 12° | 11 x 24 mm 12° | In distribution |
| 10 x 24 mm 12° | 10 x 24 mm 12° | In distribution |
| 16 x 36 mm 12° | 16 x 36 mm 12° | In distribution |
| 12 x 36 mm 18° | 12 x 36 mm 18° | In distribution |
| 16 x 30 mm 8° | 16 x 30 mm 8° | In distribution |
| 13 x 24 mm 12° | 13 x 24 mm 12° | In distribution |
| 14 x 24 mm 0° | 14 x 24 mm 0° | In distribution |
| 9 x 24 mm 12° | 9 x 24 mm 12° | In distribution |
| 14 x 36 mm 18° | 14 x 36 mm 18° | In distribution |
| 13 x 24 mm 18° | 13 x 24 mm 18° | In distribution |
| 7 x 36 mm 0° | 7 x 36 mm 0° | In distribution |
| 15 x 30 mm 0° | 15 x 30 mm 0° | In distribution |
| 16 x 36 mm 8° | 16 x 36 mm 8° | In distribution |
| 14 x 30 mm 4° | 14 x 30 mm 4° | In distribution |
| 15 x 36 mm 12° | 15 x 36 mm 12° | In distribution |
| 11 x 30 mm 0° | 11 x 30 mm 0° | In distribution |
| 14 x 30 mm 12° | 14 x 30 mm 12° | In distribution |
| 10 x 30 mm 18° | 10 x 30 mm 18° | In distribution |
| 14 x 30 mm 8° | 14 x 30 mm 8° | In distribution |
| 13 x 24 mm 8° | 13 x 24 mm 8° | In distribution |
| 15 x 24 mm 0° | 15 x 24 mm 0° | In distribution |
| 11 x 24 mm 18° | 11 x 24 mm 18° | In distribution |
| 11 x 36 mm 12° | 11 x 36 mm 12° | In distribution |
| 16 x 36 mm 0° | 16 x 36 mm 0° | In distribution |
| 14 x 36 mm 4° | 14 x 36 mm 4° | In distribution |
| 12 x 30 mm 0° | 12 x 30 mm 0° | In distribution |
| 9 x 24 mm 0° | 9 x 24 mm 0° | In distribution |
| 9 x 30 mm 18° | 9 x 30 mm 18° | In distribution |
| 12 x 24 mm 18° | 12 x 24 mm 18° | In distribution |
| 15 x 24 mm 18° | 15 x 24 mm 18° | In distribution |
| 12 x 24 mm 12° | 12 x 24 mm 12° | In distribution |
| 15 x 36 mm 0° | 15 x 36 mm 0° | In distribution |
| 13 x 36 mm 12° | 13 x 36 mm 12° | In distribution |
| 8 x 36 mm 8° | 8 x 36 mm 8° | In distribution |
| 12 x 36 mm 4° | 12 x 36 mm 4° | In distribution |
| 10 x 24 mm 8° | 10 x 24 mm 8° | In distribution |
| 10 x 30 mm 8° | 10 x 30 mm 8° | In distribution |
| 9 x 24 mm 8° | 9 x 24 mm 8° | In distribution |
| 8 x 30 mm 8° | 8 x 30 mm 8° | In distribution |
| 13 x 30 mm 8° | 13 x 30 mm 8° | In distribution |
| 16 x 24 mm 4° | 16 x 24 mm 4° | In distribution |
| 11 x 30 mm 12° | 11 x 30 mm 12° | In distribution |
| 15 x 36 mm 4° | 15 x 36 mm 4° | In distribution |
| 11 x 36 mm 4° | 11 x 36 mm 4° | In distribution |
| 16 x 30 mm 4° | 16 x 30 mm 4° | In distribution |
| 12 x 30 mm 18° | 12 x 30 mm 18° | In distribution |
| 7 x 36 mm 4° | 7 x 36 mm 4° | In distribution |
| 7 x 24 mm 0° | 7 x 24 mm 0° | In distribution |
| 11 x 24 mm 0° | 11 x 24 mm 0° | In distribution |
| 16 x 24 mm 8° | 16 x 24 mm 8° | In distribution |
| 13 x 36 mm 4° | 13 x 36 mm 4° | In distribution |
| 11 x 36 mm 8° | 11 x 36 mm 8° | In distribution |
| 15 x 30 mm 18° | 15 x 30 mm 18° | In distribution |
| 12 x 36 mm 8° | 12 x 36 mm 8° | In distribution |
| 14 x 30 mm 0° | 14 x 30 mm 0° | In distribution |
| 10 x 30 mm 12° | 10 x 30 mm 12° | In distribution |
| 13 x 36 mm 8° | 13 x 36 mm 8° | In distribution |
| 16 x 36 mm 18° | 16 x 36 mm 18° | In distribution |
| 16 x 24 mm 0° | 16 x 24 mm 0° | In distribution |
| 11 x 24 mm 4° | 11 x 24 mm 4° | In distribution |
| 12 x 36 mm 0° | 12 x 36 mm 0° | In distribution |
| 10 x 30 mm 0° | 10 x 30 mm 0° | In distribution |
| 16 x 24 mm 12° | 16 x 24 mm 12° | In distribution |
| 8 x 24 mm 0° | 8 x 24 mm 0° | In distribution |
| 16 x 24 mm 18° | 16 x 24 mm 18° | In distribution |
| 8 x 24 mm 4° | 8 x 24 mm 4° | In distribution |
| 10 x 24 mm 4° | 10 x 24 mm 4° | In distribution |
| 15 x 30 mm 12° | 15 x 30 mm 12° | In distribution |
| 12 x 36 mm 12° | 12 x 36 mm 12° | In distribution |
| 13 x 30 mm 0° | 13 x 30 mm 0° | In distribution |
| 13 x 36 mm 18° | 13 x 36 mm 18° | In distribution |
| 15 x 36 mm 18° | 15 x 36 mm 18° | In distribution |
| 13 x 24 mm 4° | 13 x 24 mm 4° | In distribution |
| 10 x 36 mm 8° | 10 x 36 mm 8° | In distribution |
| 16 x 30 mm 12° | 16 x 30 mm 12° | In distribution |
| 14 x 24 mm 4° | 14 x 24 mm 4° | In distribution |
| 13 x 30 mm 12° | 13 x 30 mm 12° | In distribution |
| 14 x 24 mm 18° | 14 x 24 mm 18° | In distribution |
| 12 x 24 mm 8° | 12 x 24 mm 8° | In distribution |
| 9 x 24 mm 4° | 9 x 24 mm 4° | In distribution |
| 9 x 24 mm 18° | 9 x 24 mm 18° | In distribution |
| 11 x 30 mm 8° | 11 x 30 mm 8° | In distribution |
| 14 x 24 mm 12° | 14 x 24 mm 12° | In distribution |
| 10 x 24 mm 0° | 10 x 24 mm 0° | In distribution |
| 15 x 30 mm 4° | 15 x 30 mm 4° | In distribution |
| 9 x 36 mm 12° | 9 x 36 mm 12° | In distribution |
| 16 x 30 mm 0° | 16 x 30 mm 0° | In distribution |
| 15 x 30 mm 8° | 15 x 30 mm 8° | In distribution |
| 15 x 24 mm 8° | 15 x 24 mm 8° | In distribution |
| 10 x 36 mm 18° | 10 x 36 mm 18° | In distribution |
| 8 x 30 mm 4° | 8 x 30 mm 4° | In distribution |
| 9 x 36 mm 8° | 9 x 36 mm 8° | In distribution |
| 9 x 36 mm 4° | 9 x 36 mm 4° | In distribution |
| 9 x 30 mm 0° | 9 x 30 mm 0° | In distribution |
| 7 x 24 mm 4° | 7 x 24 mm 4° | In distribution |
| 7 x 30 mm 0° | 7 x 30 mm 0° | In distribution |
| 13 x 30 mm 18° | 13 x 30 mm 18° | In distribution |
| 16 x 36 mm 4° | 16 x 36 mm 4° | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261067 | 2026-04-30 |
| K212050 | 2021-12-01 |
| K211413 | 2021-08-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.