L-Box®
PEEK, Ti 6Al 4V (ELI)
14manufacturers in China registered for this device type
80catalogue 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 | Inno-Health Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Record published | 2018-01-31 |
| Record revised | 2026-01-06 (version 10) |
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, serial number |
| Sizes | Length 45 to 300 mm; angle 0 to 12 °; height 8 to 14 mm; width 18 to 22 mm; outer diameter 2 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LB-141 | In distribution | |
| XLB501200 | Angle 0 ° | In distribution |
| XLB551200 | Angle 0 ° | In distribution |
| XLB451012 | Angle 12 ° | In distribution |
| XLB551007 | Angle 7 ° | In distribution |
| XLB451412 | Angle 12 ° | In distribution |
| XLC451200 | Angle 0 ° | In distribution |
| XLB451007 | Angle 7 ° | In distribution |
| LB-143 | In distribution | |
| XLC501007 | Width 22 mm | In distribution |
| XLC551407 | Width 22 mm | In distribution |
| XLB551412 | Angle 12 ° | In distribution |
| XLC501412 | Width 22 mm | In distribution |
| XLC501212 | Width 22 mm | In distribution |
| LB-125 | Length 300 mm | In distribution |
| XLB551400 | Angle 0 ° | In distribution |
| XLB551207 | Angle 7 ° | In distribution |
| LB-142 | In distribution | |
| LB-134 | In distribution | |
| XLB551000 | Angle 0 ° | In distribution |
| XLB500800 | Width 18 mm | In distribution |
| XLC550800 | Angle 0 ° | In distribution |
| XLB551212 | Angle 12 ° | In distribution |
| XLC501207 | Width 22 mm | In distribution |
| XLC500800 | Angle 0 ° | In distribution |
| LB-158 | In distribution | |
| XLB500807 | Angle 7 ° | In distribution |
| LB-072 | In distribution | |
| XLC501012 | Height 10 mm | In distribution |
| XLB451407 | Angle 7 ° | In distribution |
| XLB451212 | Angle 12 ° | In distribution |
| XLC551412 | Width 22 mm | In distribution |
| XLB501012 | Angle 12 ° | In distribution |
| XLB550807 | Angle 7 ° | In distribution |
| XLB551012 | Angle 12 ° | In distribution |
| XLC551212 | Width 22 mm | In distribution |
| LB-135 | In distribution | |
| LB-156 | In distribution | |
| XLC450807 | Angle 7 ° | In distribution |
| XLC451000 | Angle 0 ° | In distribution |
| XLB451200 | Width 18 mm | In distribution |
| XLC501400 | Angle 0 ° | In distribution |
| XLB501407 | Angle 7 ° | In distribution |
| XLC550807 | Width 22 mm | In distribution |
| XLB501207 | Angle 7 ° | In distribution |
| XLC551400 | Angle 0 ° | In distribution |
| XLC501000 | Angle 0 ° | In distribution |
| XLB501000 | Angle 0 ° | In distribution |
| XLB451207 | Angle 7 ° | In distribution |
| XLC501200 | Angle 0 ° | In distribution |
| XLB501007 | Angle 7 ° | In distribution |
| XLC451212 | Width 22 mm | In distribution |
| XLB551407 | Angle 7 ° | In distribution |
| LB-060 | In distribution | |
| XLC551207 | Width 22 mm | In distribution |
| XLB501412 | Angle 12 ° | In distribution |
| XLC501407 | Width 22 mm | In distribution |
| XLB501212 | Angle 12 ° | In distribution |
| LB-010 | In distribution | |
| XLC451007 | Angle 7 ° | In distribution |
| XLC500807 | Angle 7 ° | In distribution |
| XLB451400 | Width 18 mm | In distribution |
| LB-073 | In distribution | |
| XLB451000 | Width 18 mm | In distribution |
| XLC551012 | Width 22 mm | In distribution |
| LB-012 | In distribution | |
| XLC451412 | Width 22 mm | In distribution |
| XLC551200 | Angle 0 ° | In distribution |
| LB-131 | In distribution | |
| XLC451207 | Angle 7 ° | In distribution |
| XLB450800 | Angle 0 ° | In distribution |
| XLC551000 | Angle 0 ° | In distribution |
| XLB550800 | Angle 0 ° | In distribution |
| XLB501400 | Angle 0 ° | In distribution |
| XLB450807 | Angle 7 ° | In distribution |
| XLC451400 | Angle 0 ° | In distribution |
| XLC451012 | Width 22 mm | In distribution |
| XLC551007 | Width 22 mm | In distribution |
| XLC450800 | Angle 0 ° | In distribution |
| XLC451407 | Angle 7 ° | 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
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.