ZSFab Cervical Interbody System
ZSFab Cervical Interbody System is an additively manufactured titanium-alloy spacer for anterior cervical fusion. Its lattice structure contains near-elliptical pores and a window that can…
ZSFab Cervical Interbody System is an additively manufactured titanium-alloy spacer for anterior cervical fusion. Its lattice structure contains near-elliptical pores and a window that can be filled with bone graft.
Spacer height, length, width and lordotic angle vary across the range. The implants are used with autogenous or allogeneic bone graft, or demineralized allograft with bone marrow aspirate, and supplemental cervical fixation.
Listed Item
Cervical 16Dx18Wx11Hx15°_R
Lordosis and Fixation
Implants with a lordotic angle greater than 10 degrees require an anterior cervical plate as the supplemental fixation. The system is intended for skeletally mature patients with cervical disc degeneration or instability within C2-T1 following at least six weeks of nonoperative treatment.
7manufacturers in China registered for this device type
204catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Zsfab Inc, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K232150 |
| Record published | 2025-05-11 |
| 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 |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 5 to 12 mm; angle 0 to 20 °; depth 12 to 16 mm; width 14 to 18 mm; width 14 µm; weight 16 mg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16181115R | Depth 16 mm | In distribution |
| 14161220R | Depth 14 mm | In distribution |
| 14160707R | Depth 14 mm | In distribution |
| 12141007 | Depth 12 mm | In distribution |
| 12141215R | Depth 12 mm | In distribution |
| 12140710 | Depth 12 mm | In distribution |
| 14160615R | Depth 14 mm | In distribution |
| 12141210 | Depth 12 mm | In distribution |
| 12140615 | Depth 12 mm | In distribution |
| 12140707 | Depth 12 mm | In distribution |
| 14160907R | Depth 14 mm | In distribution |
| 16181007R | Depth 16 mm | In distribution |
| 14160900 | Depth 14 mm | In distribution |
| 12140910 | Depth 12 mm | In distribution |
| 14160820 | Depth 14 mm | In distribution |
| 14160607 | Depth 14 mm | In distribution |
| 16181115 | Depth 16 mm | In distribution |
| 12141010R | Depth 12 mm | In distribution |
| 16180610 | Depth 16 mm | In distribution |
| 12141015R | Depth 12 mm | In distribution |
| 16181010R | Depth 16 mm | In distribution |
| 12141220R | Depth 12 mm | In distribution |
| 16181200 | Depth 16 mm | In distribution |
| 12140920R | Depth 12 mm | In distribution |
| 12140810 | Depth 12 mm | In distribution |
| 16181207 | Depth 16 mm | In distribution |
| 12140920 | Depth 12 mm | In distribution |
| 16180810R | Depth 16 mm | In distribution |
| 12140510 | Depth 12 mm | In distribution |
| 14160600R | In distribution | |
| 14161100 | Depth 14 mm | In distribution |
| 16181120 | Depth 16 mm | In distribution |
| 14161110R | Depth 14 mm | In distribution |
| 12140910R | Depth 12 mm | In distribution |
| 14160500 | Depth 14 mm | In distribution |
| 12140715 | Depth 12 mm | In distribution |
| 12141215 | Depth 12 mm | In distribution |
| 16181220R | Depth 16 mm | In distribution |
| 14160510 | Depth 14 mm | In distribution |
| 14161120R | Depth 14 mm | In distribution |
| 16180715R | Depth 16 mm | In distribution |
| 12141015 | Height 12 mm | In distribution |
| 16180907 | Depth 16 mm | In distribution |
| 12140700R | Depth 12 mm | In distribution |
| 16181020 | Depth 16 mm | In distribution |
| 12140715 | Depth 12 mm | In distribution |
| 14161100R | Depth 14 mm | In distribution |
| 12141107R | Depth 12 mm | In distribution |
| 14160807R | Depth 14 mm | In distribution |
| 12141020R | Depth 12 mm | In distribution |
| 12140900 | Depth 12 mm | In distribution |
| 16180700 | Depth 16 mm | In distribution |
| 12140720R | Depth 12 mm | In distribution |
| 14161115R | Depth 14 mm | In distribution |
| 16181015R | Depth 16 mm | In distribution |
| 12141207 | Depth 12 mm | In distribution |
| 14160610R | Depth 14 mm | In distribution |
| 16180807R | Depth 16 mm | In distribution |
| 14161000 | Depth 14 mm | In distribution |
| 16180900R | Depth 16 mm | In distribution |
| 14161207 | Depth 14 mm | In distribution |
| 12140900R | Depth 12 mm | In distribution |
| 12141120 | Depth 12 mm | In distribution |
| 16180607R | Depth 16 mm | In distribution |
| 14160810 | Depth 14 mm | In distribution |
| 16181010 | Depth 16 mm | In distribution |
| 14160507 | Depth 14 mm | In distribution |
| 12141100R | Depth 12 mm | In distribution |
| 14160820R | Depth 14 mm | In distribution |
| 12140915 | Depth 12 mm | In distribution |
| 14161007R | Depth 14 mm | In distribution |
| 12141200 | Depth 12 mm | In distribution |
| 14161010R | Depth 14 mm | In distribution |
| 16181207R | Depth 16 mm | In distribution |
| 12141115 | Depth 12 mm | In distribution |
| 12141007R | Depth 12 mm | In distribution |
| 14160907 | Depth 14 mm | In distribution |
| 12140810R | Depth 12 mm | In distribution |
| 14161120 | Depth 14 mm | In distribution |
| 16181220 | Depth 16 mm | In distribution |
| 12140720 | Depth 12 mm | In distribution |
| 16180820 | Depth 16 mm | In distribution |
| 16180900 | Depth 16 mm | In distribution |
| 16180820R | Depth 16 mm | In distribution |
| 14160710 | Depth 14 mm | In distribution |
| 14160807 | Depth 14 mm | In distribution |
| 14160707 | Depth 14 mm | In distribution |
| 16180700R | Depth 16 mm | In distribution |
| 16180810 | Depth 16 mm | In distribution |
| 16180707 | Depth 16 mm | In distribution |
| 16181110 | Depth 16 mm | In distribution |
| 12140610 | Depth 12 mm | In distribution |
| 16181107R | Depth 16 mm | In distribution |
| 14160800 | Depth 14 mm | In distribution |
| 14160700R | Depth 14 mm | In distribution |
| 14160607R | Depth 14 mm | In distribution |
| 12141000R | Depth 12 mm | In distribution |
| 12140800R | Depth 12 mm | In distribution |
| 14160715R | Depth 14 mm | In distribution |
| 14160715 | Depth 14 mm | In distribution |
| 12140707R | Depth 12 mm | In distribution |
| 16181120R | Depth 16 mm | In distribution |
| 16180907R | Depth 16 mm | In distribution |
| 12140607R | Depth 12 mm | In distribution |
| 16180920 | Depth 16 mm | In distribution |
| 14161207R | Depth 14 mm | In distribution |
| 16180607 | Depth 16 mm | In distribution |
| 12140815R | Depth 12 mm | In distribution |
| 14160920 | Depth 14 mm | In distribution |
| 16180815R | Depth 16 mm | In distribution |
| 12141115R | Depth 12 mm | In distribution |
| 16180915 | Depth 16 mm | In distribution |
| 14161215R | Depth 14 mm | In distribution |
| 12141100 | Depth 12 mm | In distribution |
| 16181210R | Depth 16 mm | In distribution |
| 12140907 | Depth 12 mm | In distribution |
| 16181107 | Depth 16 mm | In distribution |
| 16180910R | Depth 16 mm | In distribution |
| 12140815 | Depth 12 mm | In distribution |
| 14160800 | Depth 14 mm | In distribution |
| 16180910 | Depth 16 mm | In distribution |
| 16180800 | Depth 16 mm | In distribution |
| 12140820R | Depth 12 mm | In distribution |
| 12140615R | Depth 12 mm | In distribution |
| 16181215 | Depth 16 mm | In distribution |
| 12140600R | Depth 12 mm | In distribution |
| 14160600 | Depth 14 mm | In distribution |
| 12140610R | Depth 12 mm | In distribution |
| 16181210 | Depth 16 mm | In distribution |
| 12140600 | Depth 12 mm | In distribution |
| 16180710R | Depth 16 mm | In distribution |
| 12140807R | Depth 12 mm | In distribution |
| 12140607 | Depth 12 mm | In distribution |
| 14161000R | Depth 14 mm | In distribution |
| 12141020 | Depth 12 mm | In distribution |
| 16181000R | Depth 16 mm | In distribution |
| 16181015 | Depth 16 mm | In distribution |
| 12140507 | Depth 12 mm | In distribution |
| 14161020 | Depth 14 mm | In distribution |
| 14161010 | Depth 14 mm | In distribution |
| 14161210R | Depth 14 mm | In distribution |
| 16180610R | Depth 16 mm | In distribution |
| 12141220 | Depth 12 mm | In distribution |
| 12141107 | Depth 12 mm | In distribution |
| 12141200R | Depth 12 mm | In distribution |
| 14160615 | Depth 14 mm | In distribution |
| 14161110 | Depth 14 mm | In distribution |
| 14160915R | Depth 14 mm | In distribution |
| 16181215R | Depth 16 mm | In distribution |
| 14160915 | Depth 14 mm | In distribution |
| 16181110R | Depth 16 mm | In distribution |
| 14161107 | Depth 14 mm | In distribution |
| 14160815R | Depth 14 mm | In distribution |
| 12141207R | Depth 12 mm | In distribution |
| 16180715 | Depth 16 mm | In distribution |
| 16180600R | Depth 16 mm | In distribution |
| 12140907 | Depth 12 mm | In distribution |
| 12140915R | Depth 12 mm | In distribution |
| 12140800 | Depth 12 mm | In distribution |
| 12140500 | Depth 12 mm | In distribution |
| 16180507 | Depth 16 mm | In distribution |
| 16180800R | Depth 16 mm | In distribution |
| 16180920R | Depth 16 mm | In distribution |
| 14161007 | Depth 14 mm | In distribution |
| 14161215 | Depth 14 mm | In distribution |
| 14161210 | Depth 14 mm | In distribution |
| 14161115 | Depth 14 mm | In distribution |
| 14160910R | Depth 14 mm | In distribution |
| 16180707R | Depth 16 mm | In distribution |
| 16181100R | Depth 16 mm | In distribution |
| 12141010 | Depth 12 mm | In distribution |
| 14160920R | Depth 14 mm | In distribution |
| 16180815 | Depth 16 mm | In distribution |
| 16181007 | Depth 16 mm | In distribution |
| 14161200 | Depth 14 mm | In distribution |
| 16180600 | Depth 16 mm | In distribution |
| 16181000 | Depth 16 mm | In distribution |
| 12140710R | Depth 12 mm | In distribution |
| 12140807 | Depth 12 mm | In distribution |
| 14161220 | Depth 14 mm | In distribution |
| 12141120R | Depth 12 mm | In distribution |
| 12141110R | Depth 12 mm | In distribution |
| 14160710R | Depth 14 mm | In distribution |
| 12141110 | Depth 12 mm | In distribution |
| 12141210 | Depth 12 mm | In distribution |
| 14161015 | Depth 14 mm | In distribution |
| 14160810R | Depth 14 mm | In distribution |
| 14161020R | Depth 14 mm | In distribution |
| 16180710 | Depth 16 mm | In distribution |
| 16180915R | Depth 16 mm | In distribution |
| 16180807 | Depth 16 mm | In distribution |
| 14161015R | Depth 14 mm | In distribution |
| 14160700 | Depth 14 mm | In distribution |
| 12140700 | Depth 12 mm | In distribution |
| 16181100 | Depth 16 mm | In distribution |
| 16180500 | Width 18 mm | In distribution |
| 14161107 | Depth 14 mm | In distribution |
| 16181200R | Depth 16 mm | In distribution |
| 12141000 | Depth 12 mm | In distribution |
| 14160910 | Depth 14 mm | In distribution |
| 14160610 | Depth 14 mm | In distribution |
| 12140820 | Depth 12 mm | In distribution |
| 14160815 | Depth 14 mm | In distribution |
| 16181020R | Depth 16 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260549 | 2026-04-24 |
| K242734 | 2024-11-07 |
| K232150 | 2023-08-18 |
| K202488 | 2021-01-07 |
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.