Data / Medical devices / China / Changzhou Yonghua Medical Instruments Co.,ltd
Changzhou Yonghua Medical Instruments Co.,ltd: FDA-registered device maker in Changzhou Jiangsu, China, 3 510(k) clearances
Changzhou Yonghua Medical Instruments Co.,ltd is registered with the FDA (registration 3012863589) in Changzhou Jiangsu, China. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 13, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012863589
- Address
- No.28 Changfan Road Wujin Economic Development Zone, Changzhou Jiangsu, China, 213100
- Owner or operator
- Changzhou Yonghua Medical Instruments Co.,Ltd (10053295)
- Roles
- Manufacturer
- First device listed
- November 17, 2016
- Registered through
- 2026
- Brand names listed
- Yonghua
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Broach | HTQ | 1 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 |
|---|---|---|---|---|---|---|
| October 13, 2016 | K160076 | XCage Interbody Fusion System | MAX | Substantially Equivalent | Ouroboros Medical, Inc. | accessdata.fda.gov |
| May 1, 2014 | K133514 | XCAGE INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | Ouroboros Medical | accessdata.fda.gov |
| August 22, 2006 | K061600 | ARX SPINAL SYSTEM | MNI | Substantially Equivalent | Life Spine | accessdata.fda.gov |
Compare with other makers
- All makers of Broach
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Reamer
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated October 13, 2016. 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.