4CIS Black Marlin Plif Cage System
4CIS Black Marlin is a posterior lumbar interbody cage system for fusion at one or two adjacent levels from L2 to S1. Its hollow implant provides space for autologous bone graft and…
4CIS Black Marlin is a posterior lumbar interbody cage system for fusion at one or two adjacent levels from L2 to S1. Its hollow implant provides space for autologous bone graft and maintains disc height and lumbar angulation.
The cage family uses PEEK or Ti-6Al-4V ELI titanium alloy. PEEK configurations contain tantalum markers for radiographic visibility, and teeth on the top and bottom surfaces engage the vertebral endplates.
Listed Item
Interbody fusion cage system for thoracolumbar spine used in PLIF procedure, made of titanium alloy and/or PEEK, designed to maintain disc height and promote spinal fusion.
Fusion Construct
The implants are supplied nonsterile for single use and require supplemental fixation. Posterior placement may use a single implant or a pair. Black Marlin is the PLIF system; the related Dolphin system uses the transforaminal approach.
14manufacturers in China registered for this device type
412catalogue 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 | Solco Biomedical Company India Private Limited, India |
|---|---|
| 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 |
| 510(k) | K213653 |
| Record published | 2026-04-24 |
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, manufacturing date, serial number |
| Sizes | Length 20 to 36 mm; angle 0 to 8 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AISP-2016-2814 | Angle 0 ° | In distribution |
| AISP-1652-2213 | Length 22 mm | In distribution |
| AISP-2017-2210 | Angle 4 ° | In distribution |
| AISP-1655-2214 | Angle 8 ° | In distribution |
| AISP-1655-2215 | Angle 8 ° | In distribution |
| AISP-2016-2516 | Angle 0 ° | In distribution |
| AISP-2018-2209 | Angle 8 ° | In distribution |
| AISP-1652-3615 | Length 36 mm | In distribution |
| AISP-1653-3608 | Length 36 mm | In distribution |
| AISP-1653-3209 | Length 32 mm | In distribution |
| AISP-1655-3215 | Angle 8 ° | In distribution |
| AISP-1653-2809 | Length 28 mm | In distribution |
| AISP-1655-3214 | Angle 8 ° | In distribution |
| AISP-1652-3611 | Length 36 mm | In distribution |
| AISP-2017-2012 | Angle 4 ° | In distribution |
| AISP-2016-3214 | Angle 0 ° | In distribution |
| AISP-2015-2013 | Length 20 mm | In distribution |
| AISP-1655-2813 | Angle 8 ° | In distribution |
| AISP-2018-3616 | Angle 8 ° | In distribution |
| AISP-2015-2212 | Length 22 mm | In distribution |
| AISP-2016-2809 | Angle 0 ° | In distribution |
| AISP-1653-3613 | Length 36 mm | In distribution |
| AISP-2016-3215 | Angle 0 ° | In distribution |
| AISP-2015-2808 | Length 28 mm | In distribution |
| AISP-1652-3211 | Length 32 mm | In distribution |
| AISP-1654-2510 | Length 25 mm | In distribution |
| AISP-2016-2508 | Angle 0 ° | In distribution |
| AISP-1652-2811 | Length 28 mm | In distribution |
| AISP-1652-2509 | Length 25 mm | In distribution |
| AISP-2017-2016 | Angle 4 ° | In distribution |
| AISP-1655-2213 | Angle 8 ° | In distribution |
| AISP-1653-2816 | Length 28 mm | In distribution |
| AISP-1652-2808 | Length 28 mm | In distribution |
| AISP-2018-2815 | Angle 8 ° | In distribution |
| AISP-2015-2813 | Length 28 mm | In distribution |
| AISP-2017-2212 | Angle 4 ° | In distribution |
| AISP-2016-2511 | Angle 0 ° | In distribution |
| AISP-1655-2511 | Angle 8 ° | In distribution |
| AISP-1655-3613 | Angle 8 ° | In distribution |
| AISP-2017-2008 | Angle 4 ° | In distribution |
| AISP-2018-3613 | Angle 8 ° | In distribution |
| AISP-2017-2211 | Angle 4 ° | In distribution |
| AISP-1653-3611 | Length 36 mm | In distribution |
| AISP-1653-3614 | Length 36 mm | In distribution |
| AISP-1653-3210 | Length 32 mm | In distribution |
| AISP-1654-2213 | Length 22 mm | In distribution |
| AISP-2018-3610 | Angle 8 ° | In distribution |
| AISP-1655-2811 | Angle 8 ° | In distribution |
| AISP-1655-2013 | Angle 8 ° | In distribution |
| AISP-1653-3216 | Length 32 mm | In distribution |
| AISP-2016-2215 | Angle 0 ° | In distribution |
| AISP-1655-2509 | Angle 8 ° | In distribution |
| AISP-2017-2815 | Angle 4 ° | In distribution |
| AISP-1655-2210 | Angle 8 ° | In distribution |
| AISP-1654-3612 | Angle 4 ° | In distribution |
| AISP-1652-2010 | Length 20 mm | In distribution |
| AISP-2018-2810 | Angle 8 ° | In distribution |
| AISP-2015-2014 | Length 20 mm | In distribution |
| AISP-2016-3213 | Angle 0 ° | In distribution |
| AISP-1654-2512 | Length 25 mm | In distribution |
| AISP-2015-2513 | Length 25 mm | In distribution |
| AISP-2017-2010 | Angle 4 ° | In distribution |
| AISP-2017-2216 | Angle 4 ° | In distribution |
| AISP-2017-2215 | Angle 4 ° | In distribution |
| AISP-1654-3609 | Angle 4 ° | In distribution |
| AISP-2016-2012 | Angle 0 ° | In distribution |
| AISP-2016-2813 | Angle 0 ° | In distribution |
| AISP-1653-2808 | Length 28 mm | In distribution |
| AISP-1654-2014 | Length 20 mm | In distribution |
| AISP-2018-2515 | Angle 8 ° | In distribution |
| AISP-1654-3610 | Angle 4 ° | In distribution |
| AISP-1654-2811 | Length 28 mm | In distribution |
| AISP-1653-3212 | Length 32 mm | In distribution |
| AISP-1652-3208 | Length 32 mm | In distribution |
| AISP-1654-3214 | Length 32 mm | In distribution |
| AISP-1654-2516 | Length 25 mm | In distribution |
| AISP-1655-3616 | Angle 8 ° | In distribution |
| AISP-2016-2815 | Angle 0 ° | In distribution |
| AISP-2015-2213 | Length 22 mm | In distribution |
| AISP-1652-2208 | Length 22 mm | In distribution |
| AISP-2015-2215 | Length 22 mm | In distribution |
| AISP-1654-2015 | Length 20 mm | In distribution |
| AISP-2017-2512 | Angle 4 ° | In distribution |
| AISP-1654-3614 | Angle 4 ° | In distribution |
| AISP-2015-2211 | Length 22 mm | In distribution |
| AISP-1653-2813 | Length 28 mm | In distribution |
| AISP-2018-2216 | Angle 8 ° | In distribution |
| AISP-2016-2515 | Angle 0 ° | In distribution |
| AISP-2015-3612 | Length 36 mm | In distribution |
| AISP-2018-3612 | Angle 8 ° | In distribution |
| AISP-2016-2514 | Angle 0 ° | In distribution |
| AISP-1652-3209 | Length 32 mm | In distribution |
| AISP-2015-2809 | Length 28 mm | In distribution |
| AISP-1652-3610 | Length 36 mm | In distribution |
| AISP-2018-2210 | Angle 8 ° | In distribution |
| AISP-2015-3214 | Length 32 mm | In distribution |
| AISP-1655-2816 | Angle 8 ° | In distribution |
| AISP-2016-2212 | Angle 0 ° | In distribution |
| AISP-2015-2514 | Length 25 mm | In distribution |
| AISP-2016-2810 | Angle 0 ° | In distribution |
| AISP-1652-2513 | Length 25 mm | In distribution |
| AISP-2015-2810 | Length 28 mm | In distribution |
| AISP-2017-2813 | Angle 4 ° | In distribution |
| AISP-1655-2212 | Angle 8 ° | In distribution |
| AISP-1654-3209 | Length 32 mm | In distribution |
| AISP-2015-2210 | Length 22 mm | In distribution |
| AISP-2018-2816 | Angle 8 ° | In distribution |
| AISP-2016-2209 | Angle 0 ° | In distribution |
| AISP-1653-2212 | Length 22 mm | In distribution |
| AISP-1652-3214 | Length 32 mm | In distribution |
| AISP-1653-2214 | Length 22 mm | In distribution |
| AISP-1652-3616 | Length 36 mm | In distribution |
| AISP-2018-2013 | Angle 8 ° | In distribution |
| AISP-1654-3615 | Angle 4 ° | In distribution |
| AISP-2017-3216 | Angle 4 ° | In distribution |
| AISP-1653-2815 | Length 28 mm | In distribution |
| AISP-2016-3210 | Angle 0 ° | In distribution |
| AISP-1653-3615 | Length 36 mm | In distribution |
| AISP-1655-3213 | Angle 8 ° | In distribution |
| AISP-1652-2515 | Length 25 mm | In distribution |
| AISP-2018-3615 | Angle 8 ° | In distribution |
| AISP-1654-2011 | Length 20 mm | In distribution |
| AISP-2017-2812 | Angle 4 ° | In distribution |
| AISP-1655-3610 | Angle 8 ° | In distribution |
| AISP-2017-2015 | Angle 4 ° | In distribution |
| AISP-1655-2016 | Angle 8 ° | In distribution |
| AISP-1654-3211 | Length 32 mm | In distribution |
| AISP-1653-2514 | Length 25 mm | In distribution |
| AISP-1653-3213 | Length 32 mm | In distribution |
| AISP-1654-2008 | Length 20 mm | In distribution |
| AISP-1653-3610 | Length 36 mm | In distribution |
| AISP-1655-2815 | Angle 8 ° | In distribution |
| AISP-2015-2008 | Length 20 mm | In distribution |
| AISP-2018-2510 | Angle 8 ° | In distribution |
| AISP-2015-2214 | Length 22 mm | In distribution |
| AISP-1653-2508 | Length 25 mm | In distribution |
| AISP-2018-2014 | Angle 8 ° | In distribution |
| AISP-2015-3215 | Length 32 mm | In distribution |
| AISP-2017-3211 | Angle 4 ° | In distribution |
| AISP-2018-3212 | Angle 8 ° | In distribution |
| AISP-2018-2511 | Angle 8 ° | In distribution |
| AISP-1653-2510 | Length 25 mm | In distribution |
| AISP-1652-2210 | Length 22 mm | In distribution |
| AISP-1654-2211 | Length 22 mm | In distribution |
| AISP-2015-2508 | Length 25 mm | In distribution |
| AISP-1655-3212 | Angle 8 ° | In distribution |
| AISP-2017-3614 | Length 36 mm | In distribution |
| AISP-1652-3212 | Length 32 mm | In distribution |
| AISP-2018-3614 | Angle 8 ° | In distribution |
| AISP-2018-2214 | Angle 8 ° | In distribution |
| AISP-2017-3611 | Angle 4 ° | In distribution |
| AISP-1652-2009 | Length 20 mm | In distribution |
| AISP-1652-2016 | Length 20 mm | In distribution |
| AISP-1653-3214 | Length 32 mm | In distribution |
| AISP-2017-3215 | Angle 4 ° | In distribution |
| AISP-1654-2208 | Length 22 mm | In distribution |
| AISP-2018-2008 | Angle 8 ° | In distribution |
| AISP-2018-3216 | Angle 8 ° | In distribution |
| AISP-2017-2810 | Angle 4 ° | In distribution |
| AISP-1652-2212 | Length 22 mm | In distribution |
| AISP-2015-3616 | Length 36 mm | In distribution |
| AISP-2016-2011 | Angle 0 ° | In distribution |
| AISP-1653-3616 | Length 36 mm | In distribution |
| AISP-2015-3613 | Length 36 mm | In distribution |
| AISP-1654-2013 | Length 20 mm | In distribution |
| AISP-2017-3209 | Angle 4 ° | In distribution |
| AISP-1655-2512 | Angle 8 ° | In distribution |
| AISP-1654-3613 | Angle 4 ° | In distribution |
| AISP-2017-2509 | Angle 4 ° | In distribution |
| AISP-2018-2513 | Angle 8 ° | In distribution |
| AISP-2015-2814 | Length 28 mm | In distribution |
| AISP-1652-2510 | Length 25 mm | In distribution |
| AISP-2017-2014 | Angle 4 ° | In distribution |
| AISP-2018-2016 | Angle 8 ° | In distribution |
| AISP-1653-2810 | Length 28 mm | In distribution |
| AISP-1654-3213 | Length 32 mm | In distribution |
| AISP-1652-3216 | Length 32 mm | In distribution |
| AISP-2016-2808 | Angle 0 ° | In distribution |
| AISP-1654-2214 | Length 22 mm | In distribution |
| AISP-2017-2516 | Angle 4 ° | In distribution |
| AISP-2017-3210 | Angle 4 ° | In distribution |
| AISP-2016-3211 | Angle 0 ° | In distribution |
| AISP-2018-2010 | Angle 8 ° | In distribution |
| AISP-2015-2216 | Length 22 mm | In distribution |
| AISP-2017-2508 | Angle 4 ° | In distribution |
| AISP-1654-3212 | Length 32 mm | In distribution |
| AISP-1653-2513 | Length 25 mm | In distribution |
| AISP-1652-2813 | Length 28 mm | In distribution |
| AISP-1652-2516 | Length 25 mm | In distribution |
| AISP-2017-3212 | Angle 4 ° | In distribution |
| AISP-1652-2512 | Length 25 mm | In distribution |
| AISP-1655-2510 | Angle 8 ° | In distribution |
| AISP-2016-2015 | Angle 0 ° | In distribution |
| AISP-2016-2216 | Angle 0 ° | In distribution |
| AISP-2018-2009 | Angle 8 ° | In distribution |
| AISP-2016-2016 | Angle 0 ° | In distribution |
| AISP-2015-3211 | Length 32 mm | In distribution |
| AISP-2016-2214 | Angle 0 ° | In distribution |
| AISP-2015-3208 | Length 32 mm | In distribution |
| AISP-1652-3609 | Length 36 mm | In distribution |
| AISP-2016-3616 | Angle 0 ° | In distribution |
| AISP-2018-2215 | Angle 8 ° | In distribution |
| AISP-1655-3615 | Angle 8 ° | In distribution |
| AISP-2015-2816 | Length 28 mm | In distribution |
| AISP-2018-3214 | Angle 8 ° | In distribution |
| AISP-1652-2214 | Length 22 mm | In distribution |
| AISP-2016-3612 | Angle 0 ° | In distribution |
| AISP-2015-3216 | Length 32 mm | In distribution |
| AISP-1654-2515 | Length 25 mm | In distribution |
| AISP-1655-3614 | Angle 8 ° | In distribution |
| AISP-1654-2009 | Length 20 mm | In distribution |
| AISP-2016-2010 | Angle 0 ° | In distribution |
| AISP-1654-3210 | Length 32 mm | In distribution |
| AISP-1653-2014 | Length 20 mm | In distribution |
| AISP-1653-2814 | Length 28 mm | In distribution |
| AISP-1654-2514 | Length 25 mm | In distribution |
| AISP-1652-3215 | Length 32 mm | In distribution |
| AISP-2018-2012 | Angle 8 ° | In distribution |
| AISP-1653-2515 | Length 25 mm | In distribution |
| AISP-2015-3614 | Length 36 mm | In distribution |
| AISP-2015-2516 | Length 25 mm | In distribution |
| AISP-2016-3212 | Angle 0 ° | In distribution |
| AISP-1653-2211 | Length 22 mm | In distribution |
| AISP-2015-3210 | Length 32 mm | In distribution |
| AISP-1652-3614 | Length 36 mm | In distribution |
| AISP-2018-2516 | Angle 8 ° | In distribution |
| AISP-2017-3612 | Angle 4 ° | In distribution |
| AISP-2015-3610 | Length 36 mm | In distribution |
| AISP-1654-2016 | Length 20 mm | In distribution |
| AISP-1654-2212 | Length 22 mm | In distribution |
| AISP-2017-3616 | Length 36 mm | In distribution |
| AISP-1655-2014 | Angle 8 ° | In distribution |
| AISP-2017-2811 | Angle 4 ° | In distribution |
| AISP-1652-2014 | Length 20 mm | In distribution |
| AISP-1653-2811 | Length 28 mm | In distribution |
| AISP-2016-3208 | Angle 0 ° | In distribution |
| AISP-2016-2008 | Angle 0 ° | In distribution |
| AISP-2017-2213 | Angle 4 ° | In distribution |
| AISP-2017-2816 | Angle 4 ° | In distribution |
| AISP-2015-3615 | Length 36 mm | In distribution |
| AISP-1652-2816 | Length 28 mm | In distribution |
| AISP-2018-3213 | Angle 8 ° | In distribution |
| AISP-1652-3612 | Length 36 mm | In distribution |
| AISP-2015-2511 | Length 25 mm | In distribution |
| AISP-2016-2211 | Angle 0 ° | In distribution |
| AISP-1654-3611 | Angle 4 ° | In distribution |
| AISP-2017-2514 | Angle 4 ° | In distribution |
| AISP-1653-2010 | Length 20 mm | In distribution |
| AISP-1654-2813 | Length 28 mm | In distribution |
| AISP-1653-2011 | Length 20 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K213653 | 2022-12-19 |
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.