NGM Wave Plif Cage
NGM WAVE PLIF is an expandable lumbar interbody fusion cage made from PEEK-OPTIMA Natural LT1 with tantalum marker pins. Its upper and lower surfaces are roughened to increase stability and…
NGM WAVE PLIF is an expandable lumbar interbody fusion cage made from PEEK-OPTIMA Natural LT1 with tantalum marker pins. Its upper and lower surfaces are roughened to increase stability and resist movement.
The family offers different footprints and lordotic angles for posterior lumbar placement. It is intended for one or two contiguous levels from L2 to S1 in skeletally mature patients and is supplied gamma sterilized for single use.
Listed Item
NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operative outcome to the greatest extent possible. NGM WAVE® PLIF cages are made of PEEK-OPTIMA Natural and tantalum (pins) in accordance with ASTM F560. The implants are available in various heights, lengths and lordosis angles. The cranial and caudal side of the implant is fitted with teeth to achieve a good degree of anchoring of the implant.
Fusion Construct
The cage is used with autogenous or allogeneic cancellous or corticocancellous bone graft and supplemental lumbar fixation. Open and minimally invasive posterior approaches are supported. Contact with other manufacturers’ components is restricted, apart from the permitted graft materials, so compatibility depends on the complete construct.
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) | K212050 |
| Record published | 2026-07-06 |
| 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 |
|---|---|---|
| 15 x 32 mm 12° | 10 x 28 mm 0° | In distribution |
| 10 x 32 mm 6° | 10 x 28 mm 0° | In distribution |
| 11 x 24 mm 12° | 11 x 24 mm 12° | In distribution |
| 11 x 28 mm 12° | 10 x 28 mm 0° | In distribution |
| 10 x 28 mm 0° | 10 x 28 mm 0° | In distribution |
| 14 x 32 mm 12° | 14 x 32 mm 12° | In distribution |
| 15 x 28 mm 12° | 15 x 28 mm 12° | In distribution |
| 13 x 24 mm 12° | 13 x 24 mm 12° | In distribution |
| 11 x 28 mm 0° | 10 x 28 mm 0° | In distribution |
| 11 x 32 mm 12° | 10 x 28 mm 0° | In distribution |
| 12 x 32 mm 6° | 12 x 32 mm 6° | In distribution |
| 11 x 32 mm 6° | 10 x 28 mm 0° | In distribution |
| 14 x 28 mm 12° | 14 x 28 mm 12° | In distribution |
| 11 x 24 mm 6° | 11 x 24 mm 6° | In distribution |
| 15 x 24 mm 12° | 15 x 24 mm 12° | In distribution |
| 11 x 24 mm 0° | 10 x 28 mm 0° | In distribution |
| 11 x 28 mm 0° | 11 x 28 mm 0° | In distribution |
| 15 x 24 mm 12° | 10 x 28 mm 0° | In distribution |
| 12 x 28 mm 12° | 10 x 28 mm 0° | In distribution |
| 11 x 24 mm 12° | 10 x 28 mm 0° | In distribution |
| 14 x 32 mm 6° | 14 x 32 mm 6° | In distribution |
| 15 x 24 mm 0° | 15 x 24 mm 0° | In distribution |
| 14 x 24 mm 12° | 14 x 24 mm 12° | In distribution |
| 13 x 24 mm 6° | 13 x 24 mm 6° | In distribution |
| 10 x 24 mm 0° | 10 x 24 mm 0° | In distribution |
| 11 x 32 mm 0° | 11 x 32 mm 0° | In distribution |
| 13 x 28 mm 6° | 13 x 28 mm 6° | In distribution |
| 9 x 32 mm 0° | 9 x 32 mm 0° | In distribution |
| 10 x 32 mm 6° | 10 x 32 mm 6° | In distribution |
| 13 x 32 mm 6° | 13 x 32 mm 6° | In distribution |
| 12 x 28 mm 0° | 10 x 28 mm 0° | In distribution |
| 15 x 24 mm 6° | 10 x 28 mm 0° | In distribution |
| 15 x 32 mm 6° | 15 x 32 mm 6° | In distribution |
| 9 x 32 mm 12° | 9 x 32 mm 12° | In distribution |
| 14 x 28 mm 12° | 10 x 28 mm 0° | In distribution |
| 11 x 24 mm 6° | 10 x 28 mm 0° | In distribution |
| 10 x 24 mm 6° | 10 x 24 mm 6° | In distribution |
| 11 x 24 mm 0° | 11 x 24 mm 0° | In distribution |
| 11 x 32 mm 6° | 11 x 32 mm 6° | In distribution |
| 15 x 32 mm 12° | 15 x 32 mm 12° | In distribution |
| 12 x 32 mm 12° | 12 x 32 mm 12° | In distribution |
| 15 x 28 mm 6° | 15 x 28 mm 6° | In distribution |
| 14 x 24 mm 6° | 10 x 28 mm 0° | In distribution |
| 15 x 28 mm 12° | 10 x 28 mm 0° | In distribution |
| 12 x 24 mm 0° | 10 x 28 mm 0° | In distribution |
| 10 x 28 mm 0° | 10 x 28 mm 0° | In distribution |
| 10 x 32 mm 12° | 10 x 32 mm 12° | In distribution |
| 9 x 28 mm 12° | 9 x 28 mm 12° | In distribution |
| 15 x 32 mm 0° | 15 x 32 mm 0° | In distribution |
| 15 x 28 mm 0° | 15 x 28 mm 0° | In distribution |
| 13 x 24 mm 12° | 10 x 28 mm 0° | In distribution |
| 13 x 28 mm 12° | 10 x 28 mm 0° | In distribution |
| 13 x 32 mm 6° | 10 x 28 mm 0° | In distribution |
| 9 x 28 mm 0° | 9 x 28 mm 0° | In distribution |
| 12 x 24 mm 0° | 12 x 24 mm 0° | In distribution |
| 14 x 32 mm 12° | 10 x 28 mm 0° | In distribution |
| 14 x 28 mm 6° | 10 x 28 mm 0° | In distribution |
| 10 x 28 mm 12° | 10 x 28 mm 0° | In distribution |
| 13 x 32 mm 12° | 10 x 28 mm 0° | In distribution |
| 14 x 28 mm 6° | 14 x 28 mm 6° | In distribution |
| 14 x 24 mm 0° | 14 x 24 mm 0° | In distribution |
| 12 x 32 mm 6° | 10 x 28 mm 0° | In distribution |
| 10 x 32 mm 12° | 10 x 28 mm 0° | In distribution |
| 12 x 32 mm 0° | 12 x 32 mm 0° | In distribution |
| 12 x 28 mm 12° | 12 x 28 mm 12° | In distribution |
| 12 x 24 mm 6° | 10 x 28 mm 0° | In distribution |
| 9 x 24 mm 0° | 9 x 24 mm 0° | In distribution |
| 15 x 28 mm 0° | 10 x 28 mm 0° | In distribution |
| 15 x 32 mm 6° | 10 x 28 mm 0° | In distribution |
| 13 x 24 mm 0° | 13 x 24 mm 0° | In distribution |
| 13 x 32 mm 0° | 13 x 32 mm 0° | In distribution |
| 13 x 28 mm 6° | 10 x 28 mm 0° | In distribution |
| 9 x 24 mm 6° | 9 x 24 mm 6° | In distribution |
| 13 x 32 mm 12° | 13 x 32 mm 12° | In distribution |
| 11 x 28 mm 6° | 11 x 28 mm 6° | In distribution |
| 9 x 28 mm 6° | 9 x 28 mm 6° | In distribution |
| 12 x 28 mm 6° | 10 x 28 mm 0° | In distribution |
| 10 x 28 mm 12° | 10 x 28 mm 12° | In distribution |
| 10 x 28 mm 6° | 10 x 28 mm 0° | In distribution |
| 12 x 28 mm 0° | 12 x 28 mm 0° | In distribution |
| 13 x 28 mm 0° | 10 x 28 mm 0° | In distribution |
| 11 x 28 mm 6° | 10 x 28 mm 0° | In distribution |
| 12 x 24 mm 6° | 12 x 24 mm 6° | In distribution |
| 12 x 24 mm 12° | 10 x 28 mm 0° | In distribution |
| 14 x 28 mm 0° | 14 x 28 mm 0° | In distribution |
| 9 x 24 mm 12° | 9 x 24 mm 12° | In distribution |
| 10 x 28 mm 6° | 10 x 28 mm 6° | In distribution |
| 14 x 24 mm 0° | 10 x 28 mm 0° | In distribution |
| 11 x 28 mm 12° | 11 x 28 mm 12° | In distribution |
| 13 x 28 mm 12° | 13 x 28 mm 12° | In distribution |
| 10 x 24 mm 12° | 10 x 24 mm 12° | In distribution |
| 13 x 24 mm 0° | 10 x 28 mm 0° | In distribution |
| 15 x 28 mm 6° | 10 x 28 mm 0° | In distribution |
| 10 x 32 mm 0° | 10 x 32 mm 0° | In distribution |
| 9 x 32 mm 6° | 9 x 32 mm 6° | In distribution |
| 14 x 24 mm 12° | 10 x 28 mm 0° | In distribution |
| 14 x 32 mm 6° | 10 x 28 mm 0° | In distribution |
| 13 x 28 mm 0° | 13 x 28 mm 0° | In distribution |
| 12 x 24 mm 12° | 12 x 24 mm 12° | In distribution |
| 13 x 24 mm 6° | 10 x 28 mm 0° | In distribution |
| 12 x 32 mm 12° | 10 x 28 mm 0° | In distribution |
| 15 x 24 mm 6° | 15 x 24 mm 6° | In distribution |
| 14 x 28 mm 0° | 10 x 28 mm 0° | In distribution |
| 12 x 28 mm 6° | 12 x 28 mm 6° | In distribution |
| 14 x 24 mm 6° | 14 x 24 mm 6° | In distribution |
| 11 x 32 mm 12° | 11 x 32 mm 12° | In distribution |
| 14 x 32 mm 0° | 14 x 32 mm 0° | In distribution |
| 15 x 24 mm 0° | 10 x 28 mm 0° | 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.