Neo Medical Cage Kit
Neo Cage System is an intervertebral fusion implant used with bone graft and supplemental lumbosacral spinal fixation. It is intended for skeletally mature patients with degenerative disc…
Neo Cage System is an intervertebral fusion implant used with bone graft and supplemental lumbosacral spinal fixation. It is intended for skeletally mature patients with degenerative disc disease at one or two levels from L2 to S1 who have undergone at least six months of non-operative treatment.
The cage is placed through an open posterior or transforaminal surgical approach. Different lengths, sizes and lordotic angles accommodate patient anatomy. The implanted cage supports stabilization while bone fusion develops during healing.
Listed Item
Cage kit TLIF anatomical/straight 26mm, 11-12 mm
Implant Construction
The cages are made from titanium alloy, Ti6Al4V, and are supplied sterile. The system includes implantation instruments supplied either sterile for single use or as reusable instruments.
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 | NEO Medical Inc., United States |
|---|---|
| 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) | K191796 |
| Record published | 2020-01-06 |
| Record revised | 2025-07-14 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 35 °C |
| Sizes | Height 7 to 14 mm; length 22 to 36 mm; angle 0 to 4 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS-22-13-08 | Height 14 mm | In distribution |
| AS-36-09-00 | Height 10 mm | In distribution |
| AS-22-07-04 | Height 8 mm | In distribution |
| CP-07-22-AL | Height 8 mm | In distribution |
| CP-09-22-AL | Height 10 mm | In distribution |
| AS-22-13-04 | Height 14 mm | In distribution |
| AS-36-07-00 | Height 8 mm | In distribution |
| AS-26-07-04 | Angle 4 ° | In distribution |
| AS-26-07-00 | Angle 0 ° | In distribution |
| CT-11-26-AS | Height 12 mm | In distribution |
| AC-32-10-05 | Height 10 mm | In distribution |
| AC-32-08-05 | Height 8 mm | In distribution |
| AS-26-13-04 | Angle 4 ° | In distribution |
| AS-26-09-00 | Angle 0 ° | In distribution |
| AC-32-11-05 | Height 11 mm | In distribution |
| AS-32-13-00 | Height 14 mm | In distribution |
| AC-36-13-05 | Height 13 mm | In distribution |
| AS-22-09-04 | Height 10 mm | In distribution |
| AS-22-11-04 | Height 12 mm | In distribution |
| AS-36-11-00 | Height 12 mm | In distribution |
| CP-11-22-AS | Height 12 mm | In distribution |
| AS-32-07-00 | Height 8 mm | In distribution |
| CP-07-22-AS | Height 8 mm | In distribution |
| CP-09-22-AS | Height 10 mm | In distribution |
| AC-32-07-05 | Height 7 mm | In distribution |
| AS-22-07-08 | Height 8 mm | In distribution |
| CP-11-22-AL | Height 12 mm | In distribution |
| AS-36-13-00 | Height 14 mm | In distribution |
| AS-22-11-08 | Height 12 mm | In distribution |
| AS-32-11-00 | Height 12 mm | In distribution |
| AC-36-08-05 | Height 8 mm | In distribution |
| AC-36-10-05 | Height 10 mm | In distribution |
| CT-13-26-AS | Height 14 mm | In distribution |
| AC-32-13-05 | Height 13 mm | In distribution |
| AS-32-09-00 | Height 10 mm | In distribution |
| AS-26-11-00 | Angle 0 ° | In distribution |
| CT-09-26-AS | Height 10 mm | In distribution |
| CP-13-22-AL | Height 14 mm | In distribution |
| AS-26-09-04 | Angle 4 ° | In distribution |
| AC-36-09-05 | Height 9 mm | In distribution |
| AC-36-11-05 | Height 11 mm | In distribution |
| AS-22-09-08 | Height 10 mm | In distribution |
| AS-26-13-00 | Angle 0 ° | In distribution |
| AC-32-12-05 | Height 12 mm | In distribution |
| AC-32-09-05 | Height 9 mm | In distribution |
| CP-13-22-AS | Height 14 mm | In distribution |
| AC-36-07-05 | Height 7 mm | In distribution |
| AC-32-14-05 | Height 14 mm | In distribution |
| AC-36-12-05 | Height 12 mm | In distribution |
| AS-26-11-04 | Angle 4 ° | In distribution |
| CT-07-26-AS | Height 8 mm | In distribution |
| AC-36-14-05 | Height 14 mm | 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 |
|---|---|
| K191796 | 2019-12-13 |
| K181048 | 2019-01-29 |
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.