Zhejiang Decans Medical Devices Co.,Ltd.
Jiaxing Zhejiang, CN
ZHEJIANG DECANS MEDICAL DEVICES CO.,LTD. appears in FDA device records in Jiaxing Zhejiang, CN. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Zhejiang Decans Medical Devices Co.,Ltd. between 2024 and 2026. The busiest year on record is 2026, with 8. The most recent is 2026, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253046 | HERA Interlocking Intramedullary Nailing System | HSB | Substantially Equivalent | |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | NKG | Substantially Equivalent | |
| K253130 | Dione PEEK Screw System | MBI | Substantially Equivalent | |
| K252930 | AQUA Laminoplasty Systems | NQW | Substantially Equivalent | |
| K252776 | ARIES Anterior Cervical Plate Systems | KWQ | Substantially Equivalent | |
| K252542 | LEO Spinal System | NKB | Substantially Equivalent | |
| K253213 | SAGI Cervical Cage System | OVE | Substantially Equivalent | |
| K252774 | Uni-C Cervical Cage System | OVE | Substantially Equivalent | |
| 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 | |
| K242195 | Gemini Cervical Fusion Cage System | ODP | Substantially Equivalent | |
| K242267 | Gemini Medical Cage System | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3048284429 | 3048284429 | ZHEJIANG DECANS MEDICAL DEVICES CO.,LTD. | No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing Zhejiang 314031 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- NKGPosterior Cervical Screw System
- HSBRod, Fixation, Intramedullary And Accessories
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain