Data / Medical devices / China / Suzhou Endophix Co., Ltd.
Suzhou Endophix Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 4 510(k) clearances
Suzhou Endophix Co., Ltd. is registered with the FDA (registration 3030514683) in Suzhou Jiangsu, China. It lists 17 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030514683
- Address
- Room 202, Factory No.3, Lane 151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province, P.R. CHINA, Suzhou Jiangsu, China, 215000
- Owner or operator
- Suzhou Endophix Co., Ltd. (10089613)
- Roles
- Manufacturer
- First device listed
- December 22, 2023
- Registered through
- 2026
- Brand names listed
- Arthroscopic cannula, Drill & Guide, Knee Surgery Instrument, Shoulder Surgery Instrument, Graft Preparation Platform Set, Knee Surgery Instrument, Shoulder Surgery Instrument, Tissue Suture Passer, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless), Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor, Knee Surgery Instrument, Knee Surgery Instrument, Shoulder Surgery Instrument and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| File | HTP | 1 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Manufacturer | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | K232941 | Megaloop Button System | MBI | Substantially Equivalent | Suzhou Endophix Co., Ltd. | accessdata.fda.gov |
| November 2, 2023 | K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | MBI | Substantially Equivalent | Suzhou Endophix Co., Ltd. | accessdata.fda.gov |
| June 7, 2023 | K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) | MBI | Substantially Equivalent | Suzhou Endophix Co., Ltd. | accessdata.fda.gov |
| May 23, 2023 | K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | MBI | Substantially Equivalent | Suzhou Endophix Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Surgical, Instrument
- All makers of Accessories, Arthroscopic
- All makers of Awl
- All makers of Knife, Orthopedic
- All makers of Washer, Bolt Nut
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated May 3, 2024. 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.