Data / Medical devices / China / Suzhou Microport Orthorecon Co., Ltd.
Suzhou Microport Orthorecon Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Suzhou Microport Orthorecon Co., Ltd. is registered with the FDA (registration 3014662844) in Suzhou Jiangsu, China. It lists 31 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014662844
- Address
- Building 2 and 3,N0.151,Fengli Street,Suzhou Industrial Park China (Jiangsu) Pilot Free Trade Zone Suzhou District, Suzhou Jiangsu, China, 215000
- Owner or operator
- Suzhou MicroPort OrthoRecon Co., Ltd. (10060911)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 11, 2019
- Registered through
- 2026
- Brand names listed
- EVOLUTION MPX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Contract manufacturer | accessdata.fda.gov |
| Broach | HTQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Contract manufacturer | accessdata.fda.gov |
| Clamp | HXD | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette | HTF | 1 | Contract manufacturer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Contract manufacturer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Manufacturer | accessdata.fda.gov |
| Punch, Femoral Neck | HWP | 1 | Contract manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Contract manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 28, 2025 | K244039 | MedalOne Total Knee System | JWH | Substantially Equivalent | Suzhou Microport Orthorecon Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Curette
- All makers of Caliper
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Broach
Updated February 28, 2025. 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.