ZSFab Lumbar Interbody System
The ZSFab Lumbar Interbody System uses additively manufactured titanium-alloy cages for lumbar fusion. Each implant combines a solid frame, porous lattice structures and a central cavity…
The ZSFab Lumbar Interbody System uses additively manufactured titanium-alloy cages for lumbar fusion. Each implant combines a solid frame, porous lattice structures and a central cavity for bone graft.
The upper and lower surfaces include teeth and a porous lattice, while the frame incorporates near-elliptical pores. Implants are offered in different heights, lengths, widths and lordotic angles to suit the treated anatomy.
Listed Item
Lumbar-P-TLIF32Dx10Wx17Hx00°_R
Graft and Fixation
The implants are supplied sterile and are used with supplemental lumbosacral fixation. Graft options include autogenous or allogeneic cancellous or corticocancellous bone, or demineralized allograft with bone marrow aspirate. The lumbar indication covers one or two adjacent levels from L2 to S1 in skeletally mature patients.
14manufacturers in China registered for this device type
550catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Zsfab Inc, 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) | K221858 |
| Record published | 2025-12-30 |
| Record revised | 2026-02-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 0 to 17 mm; depth 14 to 32 mm; width 9 to 12 mm; angle 0 to 20 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LPT32101700R | Depth 32 mm | In distribution |
| LPT24110806R | Depth 24 mm | In distribution |
| LPT24111500R | Depth 24 mm | In distribution |
| LPT24101215R | Depth 24 mm | In distribution |
| LPT28101515R | Depth 28 mm | In distribution |
| LPT20111700R | Depth 20 mm | In distribution |
| LPT20101600R | Depth 20 mm | In distribution |
| LPT20101300R | Depth 20 mm | In distribution |
| LPT20111506R | Depth 20 mm | In distribution |
| LPT28111600R | Depth 28 mm | In distribution |
| LPT20111420R | Depth 20 mm | In distribution |
| LPT32110700R | Depth 32 mm | In distribution |
| LPT20101710R | Depth 20 mm | In distribution |
| LPT24101006 | Depth 24 mm | In distribution |
| LPT24111120R | Depth 24 mm | In distribution |
| LPT28091210R | Depth 28 mm | In distribution |
| LPT24101206 | Depth 24 mm | In distribution |
| LPT20101400R | Depth 20 mm | In distribution |
| LPT24101100R | Depth 24 mm | In distribution |
| LPT28091610R | Angle 10 ° | In distribution |
| LPT24101000R | Depth 24 mm | In distribution |
| LPT24091615R | Depth 24 mm | In distribution |
| LPT24091300R | Depth 24 mm | In distribution |
| LPT28101510R | Depth 28 mm | In distribution |
| LPT24101300 | Depth 24 mm | In distribution |
| LPT20101610R | Depth 20 mm | In distribution |
| LPT32111706R | Depth 32 mm | In distribution |
| LPT28101215R | Depth 28 mm | In distribution |
| LPT32101715R | Depth 32 mm | In distribution |
| LPT32101415R | Depth 32 mm | In distribution |
| LPT32091520R | Depth 32 mm | In distribution |
| LPT24091710R | Depth 24 mm | In distribution |
| LPT20101006R | Depth 20 mm | In distribution |
| LPT24090800R | Depth 24 mm | In distribution |
| LPT20101715R | Depth 20 mm | In distribution |
| LPT24111100R | Height 11 mm | In distribution |
| LPT20110910R | Depth 20 mm | In distribution |
| LPT24111320R | Depth 24 mm | In distribution |
| LT31120808 | Depth 31 mm | In distribution |
| LPT32091400R | Depth 32 mm | In distribution |
| LPT24100600R | Depth 24 mm | In distribution |
| LPT32111510R | Depth 32 mm | In distribution |
| LPT24111200R | Depth 24 mm | In distribution |
| LPT28111200R | Depth 28 mm | In distribution |
| LPT24090910R | Depth 24 mm | In distribution |
| LPT28111115R | Depth 28 mm | In distribution |
| LPT20100800 | Depth 20 mm | In distribution |
| LPT28091110R | Depth 28 mm | In distribution |
| LPT32111300R | Depth 32 mm | In distribution |
| LPT28091515R | Depth 28 mm | In distribution |
| LPT24091006R | Depth 24 mm | In distribution |
| LPT28101010R | Depth 28 mm | In distribution |
| LPT28101710R | Depth 28 mm | In distribution |
| LPT28100806R | Depth 28 mm | In distribution |
| LPT20101410R | Depth 20 mm | In distribution |
| LPT20110810R | Depth 20 mm | In distribution |
| LPT24111220R | Depth 24 mm | In distribution |
| LPT28101104 | Depth 28 mm | In distribution |
| LPT28101006 | Depth 28 mm | In distribution |
| LPT20101110R | Depth 20 mm | In distribution |
| LPT28101310R | Depth 28 mm | In distribution |
| LPT28091410R | Depth 28 mm | In distribution |
| LPT28101115R | Depth 28 mm | In distribution |
| LPT28091715R | Depth 28 mm | In distribution |
| LPT20111220R | Depth 20 mm | In distribution |
| LPT28101420R | Depth 28 mm | In distribution |
| LPT20101106 | Depth 20 mm | In distribution |
| LPT24091200R | Depth 24 mm | In distribution |
| LPT32090910R | Depth 32 mm | In distribution |
| LPT24100700R | Depth 24 mm | In distribution |
| LPT32091700R | Depth 32 mm | In distribution |
| LPT28111415R | Depth 28 mm | In distribution |
| LPT32091720R | Depth 32 mm | In distribution |
| LPT24100706R | Depth 24 mm | In distribution |
| LPT24101710R | Depth 24 mm | In distribution |
| LPT28091720R | Depth 28 mm | In distribution |
| LPT32101410R | Depth 32 mm | In distribution |
| LPT28091706R | Depth 28 mm | In distribution |
| LPT20101415R | Depth 20 mm | In distribution |
| LPT28091520R | Depth 28 mm | In distribution |
| LPT28091406R | Depth 28 mm | In distribution |
| LPT32101600R | Depth 32 mm | In distribution |
| LPT24110810R | Depth 24 mm | In distribution |
| LPT28111520R | Depth 28 mm | In distribution |
| LPT24101400R | Depth 24 mm | In distribution |
| LPT20101200R | Depth 20 mm | In distribution |
| LPT28091206R | Depth 28 mm | In distribution |
| LPT28111215R | Depth 28 mm | In distribution |
| LPT32101420R | Depth 32 mm | In distribution |
| LPT20100906 | Depth 20 mm | In distribution |
| LPT28101706R | Depth 28 mm | In distribution |
| LPT20111720R | Depth 20 mm | In distribution |
| LPT28110900R | Depth 28 mm | In distribution |
| LPT28101208 | Depth 28 mm | In distribution |
| LPT24111600R | Depth 24 mm | In distribution |
| LPT28091306R | Depth 28 mm | In distribution |
| LPT28101300R | Depth 28 mm | In distribution |
| LPT28111315R | Depth 28 mm | In distribution |
| LPT32091510R | Depth 32 mm | In distribution |
| LPT28101715R | Depth 28 mm | In distribution |
| LPT28100808 | Depth 28 mm | In distribution |
| LPT28101304 | Depth 28 mm | In distribution |
| LPT28091215R | Depth 28 mm | In distribution |
| LPT24110906R | Depth 24 mm | In distribution |
| LPT28091200R | Depth 28 mm | In distribution |
| LPT32110800R | Depth 32 mm | In distribution |
| LPT20111710R | Depth 20 mm | In distribution |
| LPT24100800R | Depth 24 mm | In distribution |
| LPT24101506R | Depth 24 mm | In distribution |
| LPT20101606R | In distribution | |
| LPT24111410R | Depth 24 mm | In distribution |
| LPT24111620R | Depth 24 mm | In distribution |
| LPT28101520R | Depth 28 mm | In distribution |
| LPT28111300R | Depth 28 mm | In distribution |
| LPT28101100 | Depth 28 mm | In distribution |
| LPT28111610R | Depth 28 mm | In distribution |
| LPT28111720R | Depth 28 mm | In distribution |
| LPT24111615R | Depth 24 mm | In distribution |
| LPT24111515R | Depth 24 mm | In distribution |
| LPT32091620R | Depth 32 mm | In distribution |
| LPT28090910R | Depth 28 mm | In distribution |
| LPT28091420R | Depth 28 mm | In distribution |
| LPT20101206 | Depth 20 mm | In distribution |
| LPT32111520R | Depth 32 mm | In distribution |
| LPT20100810R | Depth 20 mm | In distribution |
| LPT24091606R | Depth 24 mm | In distribution |
| LPT32101206R | Depth 32 mm | In distribution |
| LPT32091215R | Depth 32 mm | In distribution |
| LPT28101200R | Depth 28 mm | In distribution |
| LPT32091410R | Depth 32 mm | In distribution |
| LPT28091600R | Depth 28 mm | In distribution |
| LPT28101308 | Depth 28 mm | In distribution |
| LPT24091420R | Depth 24 mm | In distribution |
| LPT28100908 | Depth 28 mm | In distribution |
| LPT20101206R | Depth 20 mm | In distribution |
| LPT32101615R | Height 16 mm | In distribution |
| LPT28090800R | Depth 28 mm | In distribution |
| LPT28101004 | Depth 28 mm | In distribution |
| LPT24091215R | Depth 24 mm | In distribution |
| LPT20111215R | Depth 20 mm | In distribution |
| LPT28091320R | Depth 28 mm | In distribution |
| LPT28101206 | Depth 28 mm | In distribution |
| LPT24101015R | Depth 24 mm | In distribution |
| LPT24100906 | Depth 24 mm | In distribution |
| LPT32111615R | Depth 32 mm | In distribution |
| LPT24101010R | Depth 24 mm | In distribution |
| LPT24111706R | Depth 24 mm | In distribution |
| LPT24111510R | Depth 24 mm | In distribution |
| LPT28101315R | Depth 28 mm | In distribution |
| LPT32111110R | Depth 32 mm | In distribution |
| LPT24111215R | Depth 24 mm | In distribution |
| LPT28101320R | Depth 28 mm | In distribution |
| LPT32111420R | Depth 32 mm | In distribution |
| LPT24091500R | Depth 24 mm | In distribution |
| LPT28091106R | Depth 28 mm | In distribution |
| LPT32111610R | Depth 32 mm | In distribution |
| LPT24100800 | Depth 24 mm | In distribution |
| LPT24091106R | Depth 24 mm | In distribution |
| LPT24111415R | Depth 24 mm | In distribution |
| LPT28100906R | Depth 28 mm | In distribution |
| LPT24111520R | Depth 24 mm | In distribution |
| LPT28101606R | Depth 28 mm | In distribution |
| LPT32101000R | Depth 32 mm | In distribution |
| LPT32101706R | Depth 32 mm | In distribution |
| LPT20111210R | Depth 20 mm | In distribution |
| LPT20101120R | Depth 20 mm | In distribution |
| LPT24101100 | Depth 24 mm | In distribution |
| LPT24100900R | Depth 24 mm | In distribution |
| LPT28101406R | Depth 28 mm | In distribution |
| LPT28091310R | Depth 28 mm | In distribution |
| LPT32111720R | Depth 32 mm | In distribution |
| LPT20100906R | Depth 20 mm | In distribution |
| LPT32101210R | Depth 32 mm | In distribution |
| LPT28111710R | Depth 28 mm | In distribution |
| LPT32091206R | Depth 32 mm | In distribution |
| LPT24111610R | Depth 24 mm | In distribution |
| LPT32111206R | Depth 32 mm | In distribution |
| LPT28111715R | Depth 28 mm | In distribution |
| LPT24101520R | Depth 24 mm | In distribution |
| LPT28101500R | Depth 28 mm | In distribution |
| LT31121104 | Depth 31 mm | In distribution |
| LPT28101306 | Depth 28 mm | In distribution |
| LPT32101710R | Depth 32 mm | In distribution |
| LPT24091520R | Depth 24 mm | In distribution |
| LPT28100910R | Depth 28 mm | In distribution |
| LPT32091515R | Depth 32 mm | In distribution |
| LPT24111406R | Depth 24 mm | In distribution |
| LPT24101700R | Depth 24 mm | In distribution |
| LPT24111310R | Depth 24 mm | In distribution |
| LPT20111615R | Depth 20 mm | In distribution |
| LPT24101320R | Depth 24 mm | In distribution |
| LPT28101410R | Depth 28 mm | In distribution |
| LPT20101306 | Depth 20 mm | In distribution |
| LT31121108 | Depth 31 mm | In distribution |
| LPT20101100R | Depth 20 mm | In distribution |
| LPT32111000R | Depth 32 mm | In distribution |
| LPT24110706R | Depth 24 mm | In distribution |
| LPT28101204 | Depth 28 mm | In distribution |
| LPT24111015R | Depth 24 mm | In distribution |
| LPT24111710R | Depth 24 mm | In distribution |
| LPT20101100 | Depth 20 mm | In distribution |
| LPT20101706R | Depth 20 mm | In distribution |
| LPT32111620R | Depth 32 mm | In distribution |
| LPT32101720R | Depth 32 mm | In distribution |
| LPT24101406 | Depth 24 mm | In distribution |
| LPT20110906R | Depth 20 mm | In distribution |
| LPT28111206R | Depth 28 mm | In distribution |
| LPT32091310R | Depth 32 mm | In distribution |
| LPT20111100R | Depth 20 mm | In distribution |
| LPT28101106R | Depth 28 mm | In distribution |
| LPT24101500R | Depth 24 mm | In distribution |
| LPT24111010R | Depth 24 mm | In distribution |
| LPT20101400 | Depth 20 mm | In distribution |
| LPT28111620R | Depth 28 mm | In distribution |
| LPT28101210R | Depth 28 mm | In distribution |
| LPT20101115R | Depth 20 mm | In distribution |
| LPT24091510R | Depth 24 mm | In distribution |
| LPT32101010R | Depth 32 mm | In distribution |
| LPT28101600R | Depth 28 mm | In distribution |
| LPT20101215R | Depth 20 mm | In distribution |
| LPT24111006R | Depth 24 mm | In distribution |
| LPT28091615R | Depth 28 mm | In distribution |
| LPT28111515R | Depth 28 mm | In distribution |
| LPT32111010R | Depth 32 mm | In distribution |
| LT31121408 | Depth 31 mm | In distribution |
| LPT20101315R | Depth 20 mm | In distribution |
| LPT20111610R | Depth 20 mm | In distribution |
| LPT24101706R | Depth 24 mm | In distribution |
| LPT20100806 | Depth 20 mm | In distribution |
| LPT24111110R | Depth 24 mm | In distribution |
| LPT32100700R | Depth 32 mm | In distribution |
| LPT32091110R | Depth 32 mm | In distribution |
| LPT24091110R | Depth 24 mm | In distribution |
| LPT20110900R | Depth 20 mm | In distribution |
| LPT20101515R | Depth 20 mm | In distribution |
| LPT24101206R | Depth 24 mm | In distribution |
| LT31121404 | Depth 31 mm | In distribution |
| LPT24091210R | Depth 24 mm | In distribution |
| LPT28101400R | Depth 28 mm | In distribution |
| LPT32091300R | Depth 32 mm | In distribution |
| LPT24091010R | Depth 24 mm | In distribution |
| LPT32090806R | Depth 32 mm | In distribution |
| LPT24111506R | Depth 24 mm | In distribution |
| LPT28091115R | Depth 28 mm | In distribution |
| LPT28101415R | Depth 28 mm | In distribution |
| LPT32111310R | Depth 32 mm | In distribution |
| LPT28110800R | Depth 28 mm | In distribution |
| LPT32101620R | Depth 32 mm | In distribution |
| LPT32111415R | Depth 32 mm | In distribution |
| LPT32091406R | Depth 32 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 |
|---|---|
| K252610 | 2025-11-25 |
| K221858 | 2022-10-14 |
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.