Suzhou Endophix Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3030514683
- Devices
- 145
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Suzhou Endophix Co., Ltd. makes
Suzhou Endophix Co., Ltd. manufactures orthopedic fixation devices, including the Megaloop Button System for bone stabilization and a range of suture anchors for tendon and ligament repair. Their product line includes PEEK interference screws and sheaths for soft tissue attachment, as well as titanium suture anchors for joint and tendon reattachment procedures.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) pathway. Their products are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.
Catalogue
Search and filter all 145 devicesShowing 1-50 of 145
Company details
- FDA FEI number
- 3030514683
- DUNS number
- 620899345
- Address
- Room 202, Factory No.3, Lane 151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province, P.R. CHINA, Suzhou Jiangsu
Frequently asked questions
How many devices does Suzhou Endophix Co., Ltd. have in the registry?
The registry currently lists 145 devices for Suzhou Endophix Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Endophix Co., Ltd.'s devices?
Among its 50 most recently registered devices, Suzhou Endophix Co., Ltd. has devices listed in FDA GUDID (50 devices).
What risk classes do Suzhou Endophix Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Suzhou Endophix Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Endophix Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou Endophix Co., Ltd. include endophix MS-2025PS-7, endophix MS-2025PS-6, endophix MS-2025PS-8 and endophix MS-2025PS-9.