Suzhou Endophix Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 17 device types, 15 products catalogued, 4 clearances.
Suzhou Endophix Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Awl, File and 15 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
17device types registered with the FDA
15products catalogued under its own name
4510(k) clearances
Registration
| Registered name | SUZHOU ENDOPHIX CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3030514683 |
| FEI number | 3030514683 |
| DUNS | 620899345 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 苏州竞捷医疗科技有限公司 |
|---|---|
| Unified social credit code | 91320594MA26J3JA0F |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Room 202, Factory No.3, Lane 151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province, P.R. CHINA |
| Postal code | 215000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Arthroscopic | Class 1 | Arthroscopic cannula | 2023 | 14 |
| Awl | Class 1 | Knee Surgery Instrument, Shoulder Surgery Instrument | 2023 | 13 |
| Bit, Drill | Class 1 | Drill & Guide, Knee Surgery Instrument, Shoulder Surgery Instrument | 2023 | 27 |
| Blade, Saw, General & Plastic Surgery, Surgical | Class 1 | Single-use Shaver Blade | 2023 | 25 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Class 2 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor, Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath, Megaloop Button System, 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) | 2023 | 7 |
| File | Class 1 | Knee Surgery Instrument, Shoulder Surgery Instrument | 2023 | 9 |
| Forceps | Class 1 | Orthopedic Surgical Instrument, Shoulder Surgery Instrument | 2023 | 99 |
| Gauge, Depth | Class 1 | Knee Surgery Instrument | 2023 | 14 |
| Guide, Surgical, Instrument | Class 1 | Knee Surgery Instrument, Shoulder Surgery Instrument | 2023 | 26 |
| Knife, Orthopedic | Class 1 | Knee Surgery Instrument | 2023 | 7 |
| Orthopedic Manual Surgical Instrument | Class 1 | Graft Preparation Platform Set, Knee Surgery Instrument, Shoulder Surgery Instrument, Tissue Suture Passer, Rotator Cuff Repair Instrument, Shoulder Surgery Instrument | 2023 | 53 |
| Passer, Wire, Orthopedic | Class 1 | Orthopedic Passer Instrument, Shoulder Surgery Instrument | 2023 | 9 |
| Positioner, Socket | Class 1 | Knee Surgery Instrument, Shoulder Surgery Instrument | 2023 | 4 |
| Probe | Class 1 | Knee Surgery Instrument, Shoulder Surgery Instrument | 2023 | 12 |
| Screw, Fixation, Bone | Class 2 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | 2023 | 31 |
| Screwdriver | Class 1 | Knee Surgery Instrument | 2023 | 18 |
| Washer, Bolt Nut | Class 2 | Megaloop Button System | 2024 | 9 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| endophix | MBI | 71 |
| endophix | GFA | 18 |
| endophix | HXI | 14 |
| endophix | HTW | 8 |
| endophix | NBH | 6 |
| endophix | HWJ | 5 |
| endophix | HWC | 4 |
| endophix | KIL | 4 |
| endophix | HTD | 3 |
| endophix | LXH | 2 |
| endophix | HXB | 2 |
| endophix | HTJ | 1 |
| endophix | HTP | 1 |
| endophix | HXX | 1 |
| endophix | HTS | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232941 | 2024-05-03 | MBI | Traditional | This company |
| K232725 | 2023-11-02 | MBI | Traditional | This company |
| K231002 | 2023-06-07 | MBI | Traditional | This company |
| K230874 | 2023-05-23 | MBI | Traditional | This company |
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.
The manufacturer named here can complete this record.