EZ-Track
Cervical Cage, Domed, 15 X 13 X 10MM -0°
7manufacturers in China registered for this device type
95catalogue numbers in this listing
1510(k) clearance
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 | Next Orthosurgical, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K161608 |
| Record published | 2024-09-12 |
| Record revised | 2025-07-02 (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 |
| Sizes | Length 12 to 14 mm; height 5 to 12 mm; angle 0 to 6 °; width 14 to 16 mm; weight 16 mg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CJBB151308G | Width 15 mm | In distribution |
| CJBB151310A | Width 15 mm | In distribution |
| CJAB161409A | Width 16 mm | In distribution |
| CJAB161411G | Width 16 mm | In distribution |
| CJBB141212A | Width 14 mm | In distribution |
| CJAB141207A | Width 14 mm | In distribution |
| CJBB161409A | Width 16 mm | In distribution |
| CJAB151311A | Width 15 mm | In distribution |
| CJAB151306G | Width 15 mm | In distribution |
| CJBB151306G | Width 15 mm | In distribution |
| CJAB161408G | Width 16 mm | In distribution |
| CJAB161410A | Width 16 mm | In distribution |
| CJBB151312A | Width 15 mm | In distribution |
| CJAB161412A | Width 16 mm | In distribution |
| CJAB151312A | Width 15 mm | In distribution |
| CJBB151309G | Width 15 mm | In distribution |
| CJBB151309A | Width 15 mm | In distribution |
| CJBB151311A | Width 15 mm | In distribution |
| CJAB151308G | Width 15 mm | In distribution |
| CJBB151307G | Width 15 mm | In distribution |
| CJAB151311G | Width 15 mm | In distribution |
| CJAB161406G | Width 16 mm | In distribution |
| CJAB141212A | Width 14 mm | In distribution |
| CJAB161412G | Width 16 mm | In distribution |
| CJAB141209A | Width 14 mm | In distribution |
| CJBB141205A | Width 14 mm | In distribution |
| CJBB151305G | Width 15 mm | In distribution |
| CJAB141210A | Width 14 mm | In distribution |
| CJBB161407A | Width 16 mm | In distribution |
| CJAB141212G | Width 14 mm | In distribution |
| CJBB161406G | Width 16 mm | In distribution |
| CJBB151307A | Width 15 mm | In distribution |
| CJAB141207G | Width 14 mm | In distribution |
| CJAB151306A | Width 15 mm | In distribution |
| CJBB141207G | Width 14 mm | In distribution |
| CJBB161412A | Width 16 mm | In distribution |
| CJBB151311G | Width 15 mm | In distribution |
| CJAB151310A | Width 15 mm | In distribution |
| CJBB161411G | Width 16 mm | In distribution |
| CJAB151310G | Width 15 mm | In distribution |
| CJBB141208G | Width 14 mm | In distribution |
| CJAB141208G | Width 14 mm | In distribution |
| CJAB141206G | Width 14 mm | In distribution |
| CJAB151305G | Width 15 mm | In distribution |
| CJBB161408A | Width 16 mm | In distribution |
| CJAB151309A | Width 15 mm | In distribution |
| CJBB161405A | Width 16 mm | In distribution |
| CJBB141211G | Width 14 mm | In distribution |
| CJBB141206A | Width 14 mm | In distribution |
| CJBB161409G | Width 16 mm | In distribution |
| CJBB161408G | Width 16 mm | In distribution |
| CJAB161406A | Width 16 mm | In distribution |
| CJAB151305A | Width 15 mm | In distribution |
| CJAB141205G | Width 14 mm | In distribution |
| CJBB141206G | Width 14 mm | In distribution |
| CJAB141210G | Width 14 mm | In distribution |
| CJBB151310G | Width 15 mm | In distribution |
| CJBB141207A | Width 14 mm | In distribution |
| CJAB151309G | Width 15 mm | In distribution |
| CJAB141209G | Width 14 mm | In distribution |
| CJAB151307G | Width 15 mm | In distribution |
| CJBB141209G | Width 14 mm | In distribution |
| CJBB141211A | Width 14 mm | In distribution |
| CJBB141212G | Width 14 mm | In distribution |
| CJBB141210G | Width 14 mm | In distribution |
| CJAB151308A | Width 15 mm | In distribution |
| CJAB161409G | Width 16 mm | In distribution |
| CJBB161407G | Width 16 mm | In distribution |
| CJBB141208A | Width 14 mm | In distribution |
| CJBB151308A | Width 15 mm | In distribution |
| CJBB141209A | Width 14 mm | In distribution |
| CJBB141210A | Length 12 mm | In distribution |
| CJBB161410G | Width 16 mm | In distribution |
| CJBB151306A | Width 15 mm | In distribution |
| CJAB151312G | Width 15 mm | In distribution |
| CJBB161405G | Width 16 mm | In distribution |
| CJAB161408A | Width 16 mm | In distribution |
| CJAB151307A | Width 15 mm | In distribution |
| CJAB161407G | Width 16 mm | In distribution |
| CJAB161405G | Width 16 mm | In distribution |
| CJBB161410A | Width 16 mm | In distribution |
| CJBB161411A | Width 16 mm | In distribution |
| CJBB141205G | Width 14 mm | In distribution |
| CJBB161406A | Width 16 mm | In distribution |
| CJAB141208A | Width 14 mm | In distribution |
| CJAB161410G | Width 16 mm | In distribution |
| CJAB141211G | Width 14 mm | In distribution |
| CJAB141211A | Width 14 mm | In distribution |
| CJAB141206A | Width 14 mm | In distribution |
| CJAB161405A | Width 16 mm | In distribution |
| CJAB141205A | Width 14 mm | In distribution |
| CJAB161411A | Weight 16 mg | In distribution |
| CJBB151305A | Width 15 mm | In distribution |
| CJAB161407A | Width 16 mm | In distribution |
| CJBB151312G | Width 15 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 |
|---|---|
| K161608 | 2016-09-30 |
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.