Estremo Fibular Nail
Estremo Fibular Nail - Syndesmotic dynamic screw
17manufacturers in China registered for this device type
57catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Citieffe SRL, Italy |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer |
| 510(k) | K250197 |
| Record published | 2025-12-15 |
| Record revised | 2026-02-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Syndesmotic static screw ø3.5mm L30mm | In distribution | |
| Estremo Fibular Nail ø3.8x130mm Left | In distribution | |
| Estremo Fibular Nail ø3.3x130mm Left | In distribution | |
| Screw ø2.5mm L28mm | In distribution | |
| Syndesmotic static screw ø3.5mm L45mm | In distribution | |
| Screw ø2.5mm L22mm | In distribution | |
| Syndesmotic static screw ø3.5mm L16mm | In distribution | |
| Estremo Fibular Nail ø3.8x180mm Left | In distribution | |
| Estremo Fibular Nail guide | In distribution | |
| Syndesmotic dynamic screw ø3.5mm L65mm | In distribution | |
| Syndesmotic dynamic screw ø3.5mm L55mm | In distribution | |
| Estremo Fibular Nail ø3.8x180mm Right | In distribution | |
| Syndesmotic static screw ø3.5mm L12mm | In distribution | |
| Estremo Fibular Nail ø3.3x130mm Right | In distribution | |
| Syndesmotic dynamic screw ø3.5mm L60mm | In distribution | |
| Estremo Fibular Nail ø3.8x250mm Left | In distribution | |
| Screw ø2.5mm L8mm | In distribution | |
| Estremo Fibular Nail end cap, 2.5mm | In distribution | |
| Screw ø2.5mm L16mm | In distribution | |
| Syndesmotic static screw ø3.5mm L60mm | In distribution | |
| Syndesmotic static screw ø3.5mm L20mm | In distribution | |
| Estremo Fibular Nail 180 and 250mm proximal guide | In distribution | |
| Screw ø2.5mm L14mm | In distribution | |
| Estremo Fibular Nail end cap, standard | In distribution | |
| Estremo Fibular Nail end cap, 5mm | In distribution | |
| Syndesmotic static screw ø3.5mm L50mm | In distribution | |
| Screw ø2.5mm L12mm | In distribution | |
| Estremo Fibular Nail ø3.3x250mm Left | In distribution | |
| Syndesmotic dynamic screw ø3.5mm L40mm | In distribution | |
| Screw ø2.5mm L30mm | In distribution | |
| Estremo Fibular Nail ø3.3x250mm Right | In distribution | |
| Nail connection screw | In distribution | |
| Syndesmotic dynamic screw ø3.5mm L35mm | In distribution | |
| Syndesmotic static screw ø3.5mm L34mm | In distribution | |
| Syndesmotic static screw ø3.5mm L26mm | In distribution | |
| Screw ø2.5mm L20mm | In distribution | |
| Syndesmotic dynamic screw ø3.5mm L50mm | In distribution | |
| Screw ø2.5mm L26mm | In distribution | |
| Syndesmotic static screw ø3.5mm L36mm | In distribution | |
| Syndesmotic static screw ø3.5mm L40mm | In distribution | |
| Syndesmotic static screw ø3.5mm L14mm | In distribution | |
| Syndesmotic static screw ø3.5mm L22mm | In distribution | |
| Syndesmotic static screw ø3.5mm L28mm | In distribution | |
| Estremo Fibular Nail ø3.3x180mm Left | In distribution | |
| Estremo Fibular Nail ø3.3x180mm Right | In distribution | |
| Estremo Fibular Nail ø3.8x130mm Right | In distribution | |
| Syndesmotic static screw ø3.5mm L55mm | In distribution | |
| Syndesmotic static screw ø3.5mm L65mm | In distribution | |
| Estremo Fibular Nail ø3.8x250mm Right | In distribution | |
| Screw ø2.5mm L18mm | In distribution | |
| Screw ø2.5mm L24mm | In distribution | |
| Syndesmotic static screw ø3.5mm L38mm | In distribution | |
| Screw ø2.5mm L10mm | In distribution | |
| Syndesmotic static screw ø3.5mm L32mm | In distribution | |
| Syndesmotic dynamic screw ø3.5mm L45mm | In distribution | |
| Syndesmotic static screw ø3.5mm L24mm | In distribution | |
| Syndesmotic static screw ø3.5mm L18mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113387 | 2012-03-15 |
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.