# Zhejiang Decans Medical Devices Co.,Ltd. (manufacturer, Jiaxing Zhejiang, CN): 13 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Zhejiang Decans Medical Devices Co.,Ltd. |
| Owner / operator | ZheJiang Decans Medical Devices Co.,Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Jiaxing Zhejiang, CN |
| New listings | 13 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Orthosis, Spine, Plate, Laminoplasty, Metal; Fastener, Fixation, Nondegradable, Soft Tissue; Posterior Cervical Screw System; Intervertebral Fusion Device With Integrated Fixation, Cervical; Rod, Fixation, Intramedullary And Accessories; Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Bone Graft, Cervical |
| Product codes | MAX, NKB, KWP, NQW, MBI, NKG, OVE, HSB, KWQ, ODP |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Gemini Medical Cage System; LEO Spinal System; AQUA Laminoplasty Systems; Dione PEEK Screw System; TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems; Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor); Crius PEEK Suture Anchor System (Thread-Fix Anchor) |
| First new listing | 2026-06-25 |
| Latest new listing | 2026-06-25 |
| FDA registration number | 3048284429 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.