Zhejiang Decans Medical Devices Co.,Ltd. (manufacturer, Jiaxing Zhejiang, CN): 13 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
Zhejiang Decans Medical Devices Co.,Ltd. (Jiaxing Zhejiang): 13 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar. Its amount of 13 is top-decile (95th percentile of 2,709 records). Dated 133 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 13 · 95th percentile of 2,709 DeviceEstablishmentPulse records · 6.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 95th of 2,709 (median 2, 6.5x median) |
| Peer records CSV (500 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-06-25
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Zhejiang Decans Medical Devices Co.,Ltd. and 720 CN peers
- CN DeviceEstablishmentPulse records like this one: 720
- Zhejiang Decans Medical Devices Co.,Ltd.'s amount: 95th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $144,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 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.
What is the DeviceEstablishmentPulse record for Zhejiang Decans Medical Devices Co.,Ltd. in Jiaxing Zhejiang?
Zhejiang Decans Medical Devices Co.,Ltd. (Jiaxing Zhejiang, CN), a manufacturer, added 13 FDA device listings on 2026-06-25.
How does Zhejiang Decans Medical Devices Co.,Ltd. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 13 is 6.5x the median of 2 across 2,709 records. It is 133 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Zhejiang Decans Medical Devices Co.,Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Zhejiang Decans Medical Devices Co.,Ltd. | Jiaxing Zhejiang, CN | 13 | 95th | 2026-06-25 |
| Intuitive Surgical, Inc. | Sunnyvale, CA | 13 | 95th | 2026-10-22 |
| Intuitive Surgical, Inc. | Santa Clara, CA | 13 | 95th | 2026-10-22 |
| Biomerieux, Inc. | Hazelwood, MO | 12 | 94th | 2026-10-22 |
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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.