Data / Medical devices / China / Zhejiang Decans Medical Devices Co.,ltd.
Zhejiang Decans Medical Devices Co.,ltd.: FDA-registered device maker in Jiaxing Zhejiang, China, 11 510(k) clearances
Zhejiang Decans Medical Devices Co.,ltd. is registered with the FDA (registration 3048284429) in Jiaxing Zhejiang, China. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3048284429
- Address
- No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing Zhejiang, China, 314031
- Owner or operator
- ZheJiang Decans Medical Devices Co.,Ltd. (10096104)
- Roles
- Manufacturer
- First device listed
- June 25, 2026
- Registered through
- 2026
- Brand names listed
- AQUA Laminoplasty Systems, ARIES Anterior Cervical Plate Systems, Crius PEEK Suture Anchor System (Helicoil Anchor), Crius PEEK Suture Anchor System (Pile Anchor), Crius PEEK Suture Anchor System (Thread-Fix Anchor), Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor), Dione PEEK Screw System, Gemini Cervical Fusion Cage System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | 2 | Manufacturer | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2026 | K253046 | HERA Interlocking Intramedullary Nailing System | HSB | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| June 2, 2026 | K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | NKG | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 27, 2026 | K253130 | Dione PEEK Screw System | MBI | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 27, 2026 | K252930 | AQUA Laminoplasty Systems | NQW | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 14, 2026 | K252776 | ARIES Anterior Cervical Plate Systems | KWQ | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 29, 2026 | K252542 | LEO Spinal System | NKB | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 20, 2026 | K253213 | SAGI Cervical Cage System | OVE | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 15, 2026 | K252774 | Uni-C Cervical Cage System | OVE | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| January 31, 2025 | K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | MBI | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| November 4, 2024 | K242195 | Gemini Cervical Fusion Cage System | ODP | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
| October 8, 2024 | K242267 | Gemini Medical Cage System | MAX | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Posterior Cervical Screw System
- All makers of Orthosis, Spine, Plate, Laminoplasty, Metal
- All makers of Thoracolumbosacral Pedicle Screw System
Updated June 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.