Intervertebral Fusion Device With Bone Graft, Lumbar
HYBRID TLIF Cage L32 x W12 x D14.68 x A10 x H10
14manufacturers in China registered for this device type
381catalogue 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 | TDM Co., Ltd., South Korea |
|---|---|
| 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) | K221844 |
| Record published | 2026-06-10 |
| Record revised | 2026-06-17 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3600-3610 | In distribution | |
| 3310-3613 | In distribution | |
| 3605-2811 | In distribution | |
| 3100-2210 | In distribution | |
| 3108-2214 | In distribution | |
| 3510-3208 | In distribution | |
| 3605-2513 | In distribution | |
| 3500-3207 | In distribution | |
| 3100-2212 | In distribution | |
| 3100-3610 | In distribution | |
| 3500-2812 | In distribution | |
| 3510-3609 | In distribution | |
| 3610-3210 | In distribution | |
| 3104-2512 | In distribution | |
| 3610-2510 | In distribution | |
| 3510-2513 | In distribution | |
| 3310-2509 | In distribution | |
| 3300-2509 | In distribution | |
| 3605-2809 | In distribution | |
| 3310-2508 | In distribution | |
| 3300-2814 | In distribution | |
| 3100-3612 | In distribution | |
| 3100-3609 | In distribution | |
| 3300-3211 | In distribution | |
| 3500-3614 | In distribution | |
| 3600-3607 | In distribution | |
| 3510-2507 | In distribution | |
| 3505-3608 | In distribution | |
| 3510-2813 | In distribution | |
| 3505-3614 | In distribution | |
| 3310-2514 | In distribution | |
| 3600-3614 | In distribution | |
| 3610-3608 | In distribution | |
| 3108-3610 | In distribution | |
| 3510-3612 | In distribution | |
| 3104-2813 | In distribution | |
| 3100-2509 | In distribution | |
| 3108-3211 | In distribution | |
| 3500-3608 | In distribution | |
| 3305-3208 | In distribution | |
| 3510-3213 | In distribution | |
| 3300-2514 | In distribution | |
| 3600-2812 | In distribution | |
| 3300-2812 | In distribution | |
| 3310-3210 | In distribution | |
| 3610-3209 | In distribution | |
| 3104-3608 | In distribution | |
| 3505-2809 | In distribution | |
| 3605-2510 | In distribution | |
| 3605-3212 | In distribution | |
| 3104-2809 | In distribution | |
| 3108-2212 | In distribution | |
| 3300-3608 | In distribution | |
| 3100-2512 | In distribution | |
| 3605-3613 | In distribution | |
| 3300-2810 | In distribution | |
| 3100-2511 | In distribution | |
| 3605-3612 | In distribution | |
| 3104-3212 | In distribution | |
| 3505-2513 | In distribution | |
| 3500-2511 | In distribution | |
| 3310-3614 | In distribution | |
| 3305-3610 | In distribution | |
| 3300-3213 | In distribution | |
| 3310-3610 | In distribution | |
| 3300-2513 | In distribution | |
| 3104-2812 | In distribution | |
| 3600-3214 | In distribution | |
| 3104-2510 | In distribution | |
| 3310-2810 | In distribution | |
| 3605-2511 | In distribution | |
| 3305-2510 | In distribution | |
| 3600-3611 | In distribution | |
| 3605-2810 | In distribution | |
| 3305-2511 | In distribution | |
| 3300-3614 | In distribution | |
| 3108-3213 | In distribution | |
| 3610-2509 | In distribution | |
| 3104-2808 | In distribution | |
| 3610-3609 | In distribution | |
| 3310-3208 | In distribution | |
| 3510-3209 | In distribution | |
| 3104-2514 | In distribution | |
| 3605-3207 | In distribution | |
| 3108-3208 | In distribution | |
| 3605-3214 | In distribution | |
| 3310-3608 | In distribution | |
| 3600-2809 | In distribution | |
| 3300-2811 | In distribution | |
| 3100-3608 | In distribution | |
| 3500-2813 | In distribution | |
| 3100-2208 | In distribution | |
| 3600-2512 | In distribution | |
| 3108-2814 | In distribution | |
| 3610-2512 | In distribution | |
| 3505-2813 | In distribution | |
| 3108-2512 | In distribution | |
| 3100-2513 | In distribution | |
| 3104-3211 | In distribution | |
| 3605-3208 | In distribution | |
| 3605-3610 | In distribution | |
| 3305-3612 | In distribution | |
| 3108-2813 | In distribution | |
| 3100-2213 | In distribution | |
| 3610-2807 | In distribution | |
| 3510-2514 | In distribution | |
| 3610-3614 | In distribution | |
| 3510-3207 | In distribution | |
| 3310-3214 | In distribution | |
| 3505-3211 | In distribution | |
| 3505-2812 | In distribution | |
| 3310-2814 | In distribution | |
| 3305-3209 | In distribution | |
| 3505-3607 | In distribution | |
| 3100-3208 | In distribution | |
| 3610-2811 | In distribution | |
| 3600-3209 | In distribution | |
| 3104-2212 | In distribution | |
| 3500-3211 | In distribution | |
| 3610-2814 | In distribution | |
| 3104-2511 | In distribution | |
| 3305-3608 | In distribution | |
| 3100-3209 | In distribution | |
| 3500-2514 | In distribution | |
| 3600-2507 | In distribution | |
| 3605-3210 | In distribution | |
| 3305-3212 | In distribution | |
| 3300-3609 | In distribution | |
| 3505-3611 | In distribution | |
| 3104-2810 | In distribution | |
| 3500-3210 | In distribution | |
| 3305-2808 | In distribution | |
| 3605-2512 | In distribution | |
| 3510-3613 | In distribution | |
| 3605-3611 | In distribution | |
| 3310-2512 | In distribution | |
| 3610-2508 | In distribution | |
| 3310-3611 | In distribution | |
| 3300-2512 | In distribution | |
| 3600-3207 | In distribution | |
| 3310-2510 | In distribution | |
| 3108-2514 | In distribution | |
| 3310-2813 | In distribution | |
| 3108-2210 | In distribution | |
| 3500-3610 | In distribution | |
| 3305-2809 | In distribution | |
| 3108-2511 | In distribution | |
| 3610-3611 | In distribution | |
| 3300-2510 | In distribution | |
| 3610-3610 | In distribution | |
| 3610-3211 | In distribution | |
| 3300-2809 | In distribution | |
| 3510-3608 | In distribution | |
| 3305-2514 | In distribution | |
| 3605-2808 | In distribution | |
| 3605-3609 | In distribution | |
| 3104-3614 | In distribution | |
| 3108-2812 | In distribution | |
| 3510-3614 | In distribution | |
| 3104-2509 | In distribution | |
| 3500-3214 | In distribution | |
| 3500-2507 | In distribution | |
| 3100-3214 | In distribution | |
| 3510-3610 | In distribution | |
| 3104-2209 | In distribution | |
| 3100-3210 | In distribution | |
| 3600-3613 | In distribution | |
| 3600-3608 | In distribution | |
| 3605-3608 | In distribution | |
| 3100-2809 | In distribution | |
| 3505-3609 | In distribution | |
| 3500-2809 | In distribution | |
| 3610-2808 | In distribution | |
| 3310-2812 | In distribution | |
| 3610-3613 | In distribution | |
| 3108-2810 | In distribution | |
| 3100-2214 | In distribution | |
| 3104-3611 | In distribution | |
| 3605-2812 | In distribution | |
| 3100-2811 | In distribution | |
| 3500-2509 | In distribution | |
| 3605-2508 | In distribution | |
| 3500-2513 | In distribution | |
| 3108-2209 | In distribution | |
| 3505-3208 | In distribution | |
| 3300-3612 | In distribution | |
| 3510-2811 | In distribution | |
| 3300-3610 | In distribution | |
| 3505-2509 | In distribution | |
| 3505-2808 | In distribution | |
| 3104-3609 | In distribution | |
| 3510-2512 | In distribution | |
| 3310-2808 | In distribution | |
| 3108-2208 | In distribution | |
| 3305-3213 | In distribution | |
| 3505-2512 | In distribution | |
| 3505-3207 | In distribution | |
| 3305-2811 | In distribution | |
| 3104-3209 | In distribution | |
| 3510-2812 | In distribution | |
| 3510-2510 | In distribution | |
| 3104-3613 | In distribution | |
| 3108-3214 | In distribution | |
| 3510-2511 | In distribution | |
| 3104-2211 | In distribution | |
| 3605-3607 | In distribution | |
| 3104-3208 | In distribution | |
| 3605-2514 | In distribution | |
| 3600-2513 | In distribution | |
| 3305-2512 | In distribution | |
| 3500-3213 | In distribution | |
| 3305-3214 | In distribution | |
| 3104-3210 | In distribution | |
| 3305-2513 | In distribution | |
| 3108-2509 | In distribution | |
| 3510-3211 | In distribution | |
| 3305-2814 | In distribution | |
| 3600-2510 | In distribution | |
| 3100-2508 | In distribution | |
| 3600-3208 | In distribution | |
| 3300-3212 | In distribution | |
| 3100-3211 | In distribution | |
| 3500-2508 | In distribution | |
| 3100-3212 | In distribution | |
| 3500-3613 | In distribution | |
| 3600-2508 | In distribution | |
| 3510-3607 | In distribution | |
| 3600-3612 | In distribution | |
| 3104-2210 | In distribution | |
| 3108-3212 | In distribution | |
| 3510-2509 | In distribution | |
| 3600-3210 | In distribution | |
| 3305-3613 | In distribution | |
| 3305-2812 | In distribution | |
| 3500-3609 | In distribution | |
| 3500-2810 | In distribution | |
| 3505-3212 | In distribution | |
| 3605-2813 | In distribution | |
| 3305-2509 | In distribution | |
| 3500-3208 | In distribution | |
| 3104-3213 | In distribution | |
| 3100-2814 | In distribution | |
| 3505-3209 | In distribution | |
| 3505-2814 | In distribution | |
| 3500-3612 | In distribution | |
| 3610-3207 | In distribution | |
| 3605-3614 | In distribution | |
| 3605-2814 | In distribution | |
| 3610-2812 | In distribution | |
| 3108-2510 | 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 |
|---|---|
| K221844 | 2022-08-17 |
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.