Shanghai Sanyou Medical Co., Ltd.
Registered establishment in Shanghai, China. 6 device types, 9 clearances.
Shanghai Sanyou Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Spinal Pedicle Fixation, Thoracolumbosacral Pedicle Screw System and 4 other device types. Its earliest product listing with the FDA dates from 2014.
6device types registered with the FDA
9510(k) clearances
Registration
| Registered name | SHANGHAI SANYOU MEDICAL CO. LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011556898 |
| FEI number | 3011556898 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海三友医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 913100007743059833 |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 385 Huirong Rd, Jiading District, |
| Postal code | 201815 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | Class 2 | Katia System, Shanghai Sanyou CARMEN Cervical Fusion System | 2014 | 14 |
| Intervertebral Fusion Device With Bone Graft, Cervical | Class 2 | Shanghai Sanyou PEEK Cage System, Shanghai Sanyou CARMEN Cervical Fusion System | 2017 | 7 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | Shanghai Sanyou PEEK Cage System, Keystone/Halis/Dica/Lydia, Clif | 2017 | 14 |
| Orthosis, Spinal Pedicle Fixation | Class 2 | Adena-Zina | 2017 | 13 |
| Orthosis, Spondylolisthesis Spinal Fixation | Class 2 | Adena-Zina | 2017 | 13 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | Duetto, Adena-Zina, Zeus | 2017 | 15 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230872 | 2023-12-12 | MAX | Traditional | This company |
| K230961 | 2023-10-10 | NKB | Special | This company |
| K231931 | 2023-07-28 | NKB | Special | This company |
| K211689 | 2021-09-21 | MAX | Traditional | This company |
| K212066 | 2021-08-16 | NKB | Traditional | This company |
| K163366 | 2017-10-05 | KWQ | Traditional | This company |
| K163422 | 2017-09-18 | ODP | Traditional | This company |
| K152781 | 2016-02-12 | NKB | Traditional | This company |
| K131512 | 2013-08-07 | KWQ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | Spinal fixation systems, Minimally invasive spine systems, Lumbar interbody fusion cages, Locking plate systems, 3D-printed titanium alloy cages |
| Certifications | CNAS, STAR Market listed |
| Export markets | Europe |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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