Neospace
Transforaminal Lumbar Lordotic 12X23X4°LUMBAR
14manufacturers in China registered for this device type
74catalogue numbers in this listing
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 | Neoortho Produtos Ortopédicos S/A, Brazil |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2015-09-24 |
| Record revised | 2023-12-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2016-08-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 941.720 | In distribution | |
| 941.551 | Withdrawn | |
| 941.405 | Withdrawn | |
| 941.565 | Withdrawn | |
| 941.562 | Withdrawn | |
| 941.704 | Withdrawn | |
| 941.421 | Withdrawn | |
| 941.411 | Withdrawn | |
| 941.703 | Withdrawn | |
| 941.552 | Withdrawn | |
| 941.403 | Withdrawn | |
| 941.432 | Withdrawn | |
| 941.563 | Withdrawn | |
| 941.425 | Withdrawn | |
| 941.561 | Withdrawn | |
| 941.414 | Withdrawn | |
| 941.407 | Withdrawn | |
| 941.567 | Withdrawn | |
| 941.724 | Withdrawn | |
| 941.714 | Withdrawn | |
| 941.710 | Withdrawn | |
| 941.557 | Withdrawn | |
| 941.416 | Withdrawn | |
| 941.435 | Withdrawn | |
| 941.419 | Withdrawn | |
| 941.429 | Withdrawn | |
| 941.424 | Withdrawn | |
| 941.402 | Withdrawn | |
| 941.434 | Withdrawn | |
| 941.433 | Withdrawn | |
| 941.725 | Withdrawn | |
| 941.430 | Withdrawn | |
| 941.558 | Withdrawn | |
| 941.553 | Withdrawn | |
| 941.418 | Withdrawn | |
| 941.702 | Withdrawn | |
| 941.554 | Withdrawn | |
| 941.427 | Withdrawn | |
| 941.413 | Withdrawn | |
| 941.711 | Withdrawn | |
| 941.721 | Withdrawn | |
| 941.713 | Withdrawn | |
| 941.701 | Withdrawn | |
| 941.417 | Withdrawn | |
| 941.712 | Withdrawn | |
| 941.415 | Withdrawn | |
| 941.723 | Withdrawn | |
| 941.406 | Withdrawn | |
| 941.715 | Withdrawn | |
| 941.559 | Withdrawn | |
| 941.401 | Withdrawn | |
| 941.422 | Withdrawn | |
| 941.564 | Withdrawn | |
| 941.556 | Withdrawn | |
| 941.560 | Withdrawn | |
| 941.431 | Withdrawn | |
| 941.550 | Withdrawn | |
| 941.555 | Withdrawn | |
| 941.426 | Withdrawn | |
| 941.700 | Withdrawn | |
| 941.566 | Withdrawn | |
| 941.569 | Withdrawn | |
| 941.722 | Withdrawn | |
| 941.410 | Withdrawn | |
| 941.412 | Withdrawn | |
| 941.428 | Withdrawn | |
| 941.423 | Withdrawn | |
| 941.420 | Withdrawn | |
| 941.400 | Withdrawn | |
| 941.409 | Withdrawn | |
| 941.705 | Withdrawn | |
| 941.408 | Withdrawn | |
| 941.404 | Withdrawn | |
| 941.568 | Withdrawn |
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
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.