Zhejiang Decans Medical Devices Co., Ltd.
Registered establishment in Jiaxing, Zhejiang, China. 10 device types, 11 clearances.
Zhejiang Decans Medical Devices Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Posterior Cervical Screw System, Thoracolumbosacral Pedicle Screw System and 8 other device types. Its earliest product listing with the FDA dates from 2026.
10device types registered with the FDA
11510(k) clearances
Registration
| Registered name | ZHEJIANG DECANS MEDICAL DEVICES CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3048284429 |
| FEI number | 3048284429 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 浙江德康医疗器械有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Jiaxing |
|---|---|
| Province | Zhejiang |
| Address | No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District |
| Postal code | 314031 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | Class 2 | LEO Spinal System, TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | 2026 | 11 |
| Appliance, Fixation, Spinal Intervertebral Body | Class 2 | ARIES Anterior Cervical Plate Systems | 2026 | 14 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Class 2 | Crius PEEK Suture Anchor System (Helicoil Anchor), Crius PEEK Suture Anchor System (Pile Anchor), Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor), Crius PEEK Suture Anchor System (Thread-Fix Anchor), Dione PEEK Screw System | 2026 | 7 |
| Intervertebral Fusion Device With Bone Graft, Cervical | Class 2 | Gemini Cervical Fusion Cage System | 2026 | 7 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | Gemini Medical Cage System | 2026 | 14 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | Class 2 | Uni-C Cervical Cage System, SAGI Cervical Cage System | 2026 | 5 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | Class 2 | AQUA Laminoplasty Systems | 2026 | 1 |
| Posterior Cervical Screw System | Class 2 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | 2026 | 4 |
| Rod, Fixation, Intramedullary And Accessories | Class 2 | HERA Interlocking Intramedullary Nailing System | 2026 | 17 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | LEO Spinal System | 2026 | 15 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253046 | 2026-06-16 | HSB | Traditional | This company |
| K253195 | 2026-06-02 | NKG | Traditional | This company |
| K252930 | 2026-05-27 | NQW | Traditional | This company |
| K253130 | 2026-05-27 | MBI | Traditional | This company |
| K252776 | 2026-05-14 | KWQ | Traditional | This company |
| K252542 | 2026-04-29 | NKB | Traditional | This company |
| K253213 | 2026-04-20 | OVE | Traditional | This company |
| K252774 | 2026-04-15 | OVE | Traditional | This company |
| K243665 | 2025-01-31 | MBI | Traditional | This company |
| K242195 | 2024-11-04 | ODP | Traditional | This company |
| K242267 | 2024-10-08 | MAX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Spinal fixation systems, Trauma products, Sports medicine products, Joint systems, Orthopedic surgical instruments |
| Certifications | ISO13485, ISO9001, National high-tech enterprise certification |
| Export markets | USA (FDA clearance for spinal and sports medicine products) |
Nearby Manufacturers
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.
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