CarboClear Lumbar Cage System
A surgical tool for use with the lumbar intervertebral body fusion device (cage). The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to…
A surgical tool for use with the lumbar intervertebral body fusion device (cage). The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to assist in selection of correct implant dimensions and to verify implant position within the disc space.
14manufacturers in China registered for this device type
43catalogue numbers in this listing
1510(k) clearance
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 | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K203683 |
| Record published | 2021-01-19 |
| Record revised | 2025-07-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 10 mm; length 23 to 27 mm; height 8 to 14 mm; angle 5 to 10 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Implant Trial-10x23x14mm | In distribution | |
| Cage Inserter → Inner Rod | In distribution | |
| Shaver → 8 mm | In distribution | |
| Shaver → 14 mm | In distribution | |
| Cubic Cage | Width 10 mm | In distribution |
| Cage Inserter → Inner Rod M3 | In distribution | |
| Bone Funnel | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Shaver → 12 mm | In distribution | |
| Cubic Cage | Width 10 mm | In distribution |
| T-Handle | In distribution | |
| Shaver → 9 mm | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Shaver → 13 mm | In distribution | |
| Cubic Cage | Width 10 mm | In distribution |
| Cubic Cage | Width 10 mm | In distribution |
| Cubic Cage | Width 10 mm | In distribution |
| Implant Trial-10x23x8mm | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Cubic Cage | Width 10 mm | In distribution |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Sterilization Box | In distribution | |
| Implant Trial-10x23x10mm | In distribution | |
| Shaver → 11 mm | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Slap Graft Hammer | In distribution | |
| Cubic Cage | Width 10 mm | In distribution |
| Implant Trial-10x27x8mm | In distribution | |
| Bone Graft Tamp | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Implant Trial-10x23x12mm | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Shaver → 10 mm | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Cubic Cage | Width 10 mm | In distribution |
| Shaver → 7 mm | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Cage Inserter → Outer Part | In distribution | |
| Cubic Lordotic Cage | Width 10 mm | In distribution |
| Cubic Lordotic Cage | Width 10 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 |
|---|---|
| K193378 | 2020-03-02 |
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.