Tranquil-L Interbody System
PLIF IBD 16x9x32, Planar, 6 Deg
14manufacturers in China registered for this device type
151catalogue 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 | Nexus Spine, L.L.C., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K233375 |
| Record published | 2025-09-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 10 to 32 mm; length 9 to 60 mm; height 7 to 17 mm; height 12 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 523505s | Width 26 mm | In distribution |
| 523467s | Width 22 mm | In distribution |
| 522914s | Width 11 mm | In distribution |
| 523390s | Width 18 mm | In distribution |
| 522024s | Width 32 mm | In distribution |
| 523399s | Width 18 mm | In distribution |
| 523383s | Width 18 mm | In distribution |
| 523384s | Width 18 mm | In distribution |
| 522032s | Width 32 mm | In distribution |
| 523410s | Width 18 mm | In distribution |
| 523457s | Width 22 mm | In distribution |
| 523405s | Width 18 mm | In distribution |
| 523412s | Width 18 mm | In distribution |
| 523387s | Width 18 mm | In distribution |
| 522917s | Width 11 mm | In distribution |
| 523396s | Width 18 mm | In distribution |
| 523495s | Width 26 mm | In distribution |
| 523382s | Width 18 mm | In distribution |
| 523423s | Width 18 mm | In distribution |
| 522916s | Width 11 mm | In distribution |
| 523404s | Width 18 mm | In distribution |
| 523394s | Width 18 mm | In distribution |
| 523414s | Width 18 mm | In distribution |
| 523480s | Width 26 mm | In distribution |
| 523501s | Width 26 mm | In distribution |
| 522029s | Width 32 mm | In distribution |
| 522028s | Width 32 mm | In distribution |
| 523389s | Width 18 mm | In distribution |
| 523393s | Width 18 mm | In distribution |
| 522033s | Width 32 mm | In distribution |
| 523401s | Width 18 mm | In distribution |
| 523479s | Width 26 mm | In distribution |
| 523381s | Width 18 mm | In distribution |
| 523465s | Width 22 mm | In distribution |
| 523377s | Width 18 mm | In distribution |
| 523428s | Width 22 mm | In distribution |
| 523441s | Width 22 mm | In distribution |
| 522921s | Width 11 mm | In distribution |
| 523493s | Width 26 mm | In distribution |
| 523397s | Width 18 mm | In distribution |
| 523380s | Width 18 mm | In distribution |
| 523461s | Width 22 mm | In distribution |
| 523432s | Width 22 mm | In distribution |
| 522922s | Width 11 mm | In distribution |
| 523484s | Width 26 mm | In distribution |
| 523455s | Width 22 mm | In distribution |
| 523437s | Width 22 mm | In distribution |
| 522027s | Width 32 mm | In distribution |
| 523448s | Width 22 mm | In distribution |
| 523392s | Width 18 mm | In distribution |
| 523482s | Width 26 mm | In distribution |
| 523498s | Width 26 mm | In distribution |
| 523433s | Width 22 mm | In distribution |
| 522913s | Width 11 mm | In distribution |
| 523388s | Width 18 mm | In distribution |
| 523470s | Width 22 mm | In distribution |
| 523450s | Width 22 mm | In distribution |
| 522031s | Width 32 mm | In distribution |
| 523386s | Width 18 mm | In distribution |
| 523400s | Width 18 mm | In distribution |
| 523500s | Width 26 mm | In distribution |
| 523496s | Width 26 mm | In distribution |
| 523486s | Width 26 mm | In distribution |
| 523453s | Width 22 mm | In distribution |
| 523449s | Width 22 mm | In distribution |
| 522918s | Width 11 mm | In distribution |
| 523408s | Width 18 mm | In distribution |
| 523395s | Width 18 mm | In distribution |
| 523472s | Width 22 mm | In distribution |
| 523444s | Width 22 mm | In distribution |
| 523425s | Width 18 mm | In distribution |
| 523436s | Width 22 mm | In distribution |
| 523379s | Width 18 mm | In distribution |
| 523454s | Width 22 mm | In distribution |
| 523477s | Width 26 mm | In distribution |
| 523504s | Width 26 mm | In distribution |
| 523483s | Width 26 mm | In distribution |
| 523431s | Width 22 mm | In distribution |
| 522903s | Width 10 mm | In distribution |
| 523491s | Width 26 mm | In distribution |
| 523443s | Width 22 mm | In distribution |
| 523456s | Width 22 mm | In distribution |
| 523440s | Width 22 mm | In distribution |
| 523445s | Width 22 mm | In distribution |
| 523446s | Width 22 mm | In distribution |
| 523469s | Width 22 mm | In distribution |
| 523506s | Width 26 mm | In distribution |
| 523460s | Width 22 mm | In distribution |
| 523487s | Width 26 mm | In distribution |
| 523471s | Width 22 mm | In distribution |
| 523463s | Width 22 mm | In distribution |
| 523439s | Width 22 mm | In distribution |
| 523402s | Width 18 mm | In distribution |
| 522902s | Width 10 mm | In distribution |
| 523426s | Width 18 mm | In distribution |
| 523452s | Width 22 mm | In distribution |
| 523485s | Width 26 mm | In distribution |
| 523403s | Width 18 mm | In distribution |
| 523442s | Width 22 mm | In distribution |
| 523427s | Width 22 mm | In distribution |
| 522919s | Width 11 mm | In distribution |
| 523416s | Width 18 mm | In distribution |
| 522923s | Width 11 mm | In distribution |
| 523490s | Width 26 mm | In distribution |
| 522025s | Width 32 mm | In distribution |
| 522026s | Width 32 mm | In distribution |
| 523488s | Width 26 mm | In distribution |
| 523378s | Width 18 mm | In distribution |
| 522023s | Width 32 mm | In distribution |
| 523462s | Width 22 mm | In distribution |
| 523481s | Width 26 mm | In distribution |
| 523464s | Width 22 mm | In distribution |
| 523409s | Width 18 mm | In distribution |
| 523503s | Width 26 mm | In distribution |
| 523418s | Width 18 mm | In distribution |
| 522915s | Width 11 mm | In distribution |
| 523478s | Width 26 mm | In distribution |
| 523434s | Width 22 mm | In distribution |
| 522920s | Width 11 mm | In distribution |
| 523435s | Width 22 mm | In distribution |
| 523447s | Width 22 mm | In distribution |
| 523391s | Width 18 mm | In distribution |
| 523451s | Width 22 mm | In distribution |
| 523419s | Width 18 mm | In distribution |
| 523438s | Width 22 mm | In distribution |
| 523466s | Width 22 mm | In distribution |
| 523406s | Width 18 mm | In distribution |
| 523398s | Width 18 mm | In distribution |
| 523473s | Width 22 mm | In distribution |
| 523499s | Width 26 mm | In distribution |
| 523458s | Width 22 mm | In distribution |
| 523422s | Width 18 mm | In distribution |
| 523429s | Width 22 mm | In distribution |
| 523468s | Width 22 mm | In distribution |
| 523476s | Width 22 mm | In distribution |
| 523474s | Width 22 mm | In distribution |
| 523417s | Width 18 mm | In distribution |
| 523421s | Height 16 mm | In distribution |
| 523415s | Width 18 mm | In distribution |
| 523459s | Width 22 mm | In distribution |
| 523413s | Width 18 mm | In distribution |
| 523430s | Width 22 mm | In distribution |
| 523494s | Width 26 mm | In distribution |
| 523475s | Width 22 mm | In distribution |
| 523424s | Width 18 mm | In distribution |
| 523489s | Width 26 mm | In distribution |
| 523420s | Width 18 mm | In distribution |
| 522030s | Width 32 mm | In distribution |
| 523385s | Width 18 mm | In distribution |
| 523411s | Width 18 mm | In distribution |
| 523407s | Width 18 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
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.