EBA2
Kit composed of: - Right Nail ø10mm L300mm (1 pc); - Guide wire (1 pc). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136).
17manufacturers in China registered for this device type
125catalogue 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) | K131005 |
| Record published | 2016-10-11 |
| Record revised | 2022-09-16 (version 9) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Dry and clean environment and avoid damaging the packing. Room temperature. |
| Sizes | Outer diameter 5 to 65 mm; length 30 to 460 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Long nail ø10mm L300mm, left | Left | In distribution |
| Long nail ø10mm L300mm, right | Right | In distribution |
| Long nail ø10mm L440mm, left | Left | In distribution |
| Long nail ø9mm L360mm, right | Right | In distribution |
| Standard and medium nail guide | In distribution | |
| Long nail ø9mm L340mm, left | Left | In distribution |
| Cannulated drill bit | In distribution | |
| Trochanteric drill | In distribution | |
| Long nail ø13mm L320mm, right | Right | In distribution |
| Cephalic screws drill Hudson connection | In distribution | |
| Allen T-screwdriver, 6mm | In distribution | |
| Long nail ø10mm L460mm, left | Left | In distribution |
| Long nail proximal guide | In distribution | |
| Long nail ø11mm L380mm, right | Right | In distribution |
| Long nail ø10mm L320mm, right | Right | In distribution |
| Long nail ø9mm L300mm, left | Left | In distribution |
| Fracture alignment guide wire exchange tool | In distribution | |
| Long nail ø11mm L440mm, right | Right | In distribution |
| Multi-use ø3mm wires chuck | In distribution | |
| Long nail ø13mm L380mm, left | Left | In distribution |
| Long nail ø11mm L400mm, left | Left | In distribution |
| Medium nail L240mm | Outer Diameter 14 mm | In distribution |
| Long nail ø12mm L420mm, left | Left | In distribution |
| Long nail ø13mm L360mm, right | Right | In distribution |
| Instrument set tray | In distribution | |
| Long nail ø12mm L320mm, left | Left | In distribution |
| Cortical screw ø5mm L65mm | Outer Diameter 65 mm | In distribution |
| Cephalic screw ø7.5mm L80mm | Outer Diameter 7.5 mm | In distribution |
| Long nail ø12mm L440mm, right | Right | In distribution |
| Long nail ø13mm L400mm, left | Left | In distribution |
| Cephalic screw ø7.5mm L95mm | Outer Diameter 7.5 mm | In distribution |
| Long nail ø11mm L420mm, right | Right | In distribution |
| Cortical screw ø5mm L55mm | Length 55 mm | In distribution |
| Helical tip graduated guide wire | In distribution | |
| Long nail ø11mm L460mm, left | Left | In distribution |
| Guide wire with olive (sterile) | In distribution | |
| Nail and screw ruler | In distribution | |
| Long nail ø9mm L320mm, right | Right | In distribution |
| Allen T-wrench, 8mm | In distribution | |
| Long nail ø13mm L400mm, right | Right | In distribution |
| Long nail ø13mm L460mm, left | Left | In distribution |
| Long nail ø10mm L460mm, right | Right | In distribution |
| Cephalic screw ø7.5mm L85mm | Outer Diameter 7.5 mm | In distribution |
| Long nail ø9mm L340mm, right | Right | In distribution |
| Long nail ø12mm L360mm, right | Right | In distribution |
| Long nail ø13mm L420mm, right | Right | In distribution |
| Long nail ø10mm L400mm, right | Right | In distribution |
| Long nail ø12mm L400mm, right | Right | In distribution |
| Long nail ø12mm L420mm, right | Right | In distribution |
| Cephalic screw ø7.5mm L105mm | Outer Diameter 7.5 mm | In distribution |
| Long nail ø10mm L380mm, left | Left | In distribution |
| Long nail instrument tray | In distribution | |
| Cortical screw ø5mm L45mm | Length 45 mm | In distribution |
| Long nail ø13mm L360mm, left | Left | In distribution |
| Guide wire with olive | In distribution | |
| Cephalic screws drill | In distribution | |
| Long nail ø12mm L340mm, right | Right | In distribution |
| Long nail ø13mm L340mm, right | Right | In distribution |
| Long nail ø12mm L460mm, left | Left | In distribution |
| Long nail ø13mm L380mm, right | Right | In distribution |
| Cephalic screw ø7.5mm L70mm | Outer Diameter 6.8 mm | In distribution |
| Cannulated drill bit Hudson connection | In distribution | |
| Long nail ø12mm L380mm, left | Left | In distribution |
| Trochanteric drill for long nail | In distribution | |
| Long nail ø10mm L400mm, left | Left | In distribution |
| Long nail ø13mm L340mm, left | Left | In distribution |
| Long nail ø12mm L440mm, left | Left | In distribution |
| Long nail ø9mm L380mm, right | Right | In distribution |
| Long nail ø12mm L460mm, right | Right | In distribution |
| Long nail ø10mm L420mm, left | Left | In distribution |
| Long nail ø13mm L460mm, right | Right | In distribution |
| Cephalic screw ø7.5mm L75mm | Outer Diameter 7.5 mm | In distribution |
| Cortical screw ø5mm L75mm | Length 75 mm | In distribution |
| Long nail ø11mm L340mm, left | Left | In distribution |
| Long nail ø12mm L400mm, left | Left | In distribution |
| Trocar | In distribution | |
| Box for screws | In distribution | |
| Cortical screw ø5mm L50mm | Length 50 mm | In distribution |
| Long nail ø9mm L320mm, left | Left | In distribution |
| Long nail ø10mm L360mm, left | Left | In distribution |
| Long nail ø11mm L440mm, left | Left | In distribution |
| End cap | Outer Diameter 10.3 mm | In distribution |
| Long nail ø10mm L320mm, left | Left | In distribution |
| Disposable scalpel ø8x10mm | In distribution | |
| Cephalic screw ø7.5mm L100mm | Outer Diameter 7.5 mm | In distribution |
| Long nail ø10mm L440mm, right | Right | In distribution |
| Long nail ø10mm L340mm, right | Right | In distribution |
| Long nail ø13mm L420mm, left | Left | In distribution |
| Cephalic screw ø7.5mm L90mm | Outer Diameter 7.5 mm | In distribution |
| Cortical screw ø5mm L40mm | Length 40 mm | In distribution |
| Cortical screw ø5mm L60mm | Outer Diameter 60 mm | In distribution |
| Cortical screw ø5mm L30mm | Length 30 mm | In distribution |
| Long nail ø11mm L460mm, right | Right | In distribution |
| Long nail ø12mm L340mm, left | Left | In distribution |
| Long nail ø9mm L300mm, right | Right | In distribution |
| Long nail ø13mm L440mm, right | Right | In distribution |
| Tissue protection sleeve | In distribution | |
| Cannula | In distribution | |
| Long nail ø13mm L320mm, left | Left | In distribution |
| Long nail ø10mm L380mm, right | Right | In distribution |
| Long nail ø11mm L420mm, left | Left | In distribution |
| End cap + 15 mm | In distribution | |
| Long nail ø11mm L380mm, left | Left | In distribution |
| Long nail ø13mm L440mm, left | Left | In distribution |
| Long nail ø12mm L360mm, left | Left | In distribution |
| Long nail ø12mm L380mm, right | Right | In distribution |
| Long nail ø10mm L340mm, left | Left | In distribution |
| Cortical screw ø5mm L80mm | Length 80 mm | In distribution |
| Standard nail L180mm | Outer Diameter 13.5 mm | In distribution |
| Long nail ø11mm L320mm, left | Left | In distribution |
| Box for screws | In distribution | |
| Long nail ø9mm L380mm, left | Left | In distribution |
| Cortical screw ø5mm L70mm | Length 70 mm | In distribution |
| Long nail ø9mm L360mm, left | Left | In distribution |
| Cephalic screw ø7.5mm L110mm | Outer Diameter 7.5 mm | In distribution |
| Long nail ø11mm L360mm, right | Right | In distribution |
| Long nail ø11mm L360mm, left | Left | In distribution |
| Long nail ø10mm L420mm, right | Right | In distribution |
| Cortical screw ø5mm L35mm | Length 35 mm | In distribution |
| Long nail ø11mm L400mm, right | Right | In distribution |
| Long nail distal centering guide | In distribution | |
| Long nail ø10mm L360mm, right | Right | In distribution |
| Long nail ø11mm L340mm, right | Right | In distribution |
| Long nail ø11mm L320mm, right | Right | In distribution |
| Long nail ø12mm L320mm, right | Right | 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.