EBA ONE
200 catalogue numbers from Long nail ø13x420mm 130° left, listed by Citieffe SRL, Italy, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
200catalogue 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) | K183666 |
| Record published | 2019-12-16 |
| Record revised | 2022-09-16 (version 5) |
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. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Long nail ø13x420mm 130° left | In distribution | |
| Cardanic screwdriver, 3.5mm | In distribution | |
| Long nail ø12x380mm 130° right | In distribution | |
| Wrench, 8mm Hudson coupling | In distribution | |
| Eba One Targeting device, 130° | In distribution | |
| Long nail ø13x320mm 130° right | In distribution | |
| Long nail ø13x300mm 130° right | In distribution | |
| Cortical screw ø5.2mm L35mm | In distribution | |
| Long nail ø11x280mm 130° right | In distribution | |
| Targeting device, 125° | In distribution | |
| Long nail ø11x320mm 130° right | In distribution | |
| Long nail ø12x360mm 130° right | In distribution | |
| Long nail ø10x280mm 130° left | In distribution | |
| Long nail ø10x380mm 130° right | In distribution | |
| Long nail ø10x400mm 130° left | In distribution | |
| Long nail ø13x300mm 130° left | In distribution | |
| Long nail ø10x420mm 130° left | In distribution | |
| Long nail ø13x280mm 130° left | In distribution | |
| Eba One static cephalic screw ø10.5mm L90mm | In distribution | |
| Guide wire ø3x800mm | In distribution | |
| Long nail ø11x360mm 130° right | In distribution | |
| Cephalic screwdriver, XXL | In distribution | |
| Long nail ø11x400mm 130° right | In distribution | |
| Targeting device, 120° | In distribution | |
| Long nail ø11x300mm 130° right | In distribution | |
| Graduated drill bit, ø4mm (STERILE) | In distribution | |
| Cephalic screw ø10.5mm L115mm | In distribution | |
| Long nail ø10x300mm 130° right | In distribution | |
| Cephalic screw ø10.5mm L90mm | In distribution | |
| Cannulated awl | In distribution | |
| Guide wire, helical tip ø3x410mm | In distribution | |
| Cortical screw ø5.2mm L27.5mm | In distribution | |
| Long nail ø11x420mm 130° left | In distribution | |
| Long nail ø10x400mm 130° right | In distribution | |
| Long nail ø10x300mm 130° left | In distribution | |
| Long nail ø12x300mm 130° left | In distribution | |
| Cortical screw ø5.2mm L45mm | In distribution | |
| Eba One medium nail ø10x230mm 130° | In distribution | |
| Long nail ø12x380mm 130° left | In distribution | |
| Long nail ø10x320mm 130° left | In distribution | |
| Allen T-wrench, 8mm long | In distribution | |
| Standard nail ø11x170mm 130° | In distribution | |
| Cortical screw ø5.2mm L60mm | In distribution | |
| Cortical screw ø5.2mm L30mm | In distribution | |
| Cannulated reamer ø16mm | In distribution | |
| Trocar for stabilization wire, XXL | In distribution | |
| Long nail ø13x340mm 130° left | In distribution | |
| Nail connection bolt, Eba One guide | In distribution | |
| Long nail ø10x360mm 130° left | In distribution | |
| Long nail ø10x360mm 130° right | In distribution | |
| Cephalic screw ø10.5mm L80mm | In distribution | |
| Instrument set tray, 6 empty | In distribution | |
| Cortical screw ø5.2mm L75mm | In distribution | |
| End cap 0mm | In distribution | |
| Eba One static cephalic screw ø10.5mm L105mm | In distribution | |
| Cortical screw ø5.2mm L105mm | In distribution | |
| Instrument set tray, 5 empty | In distribution | |
| Long nail ø10x380mm 130° left | In distribution | |
| Impactor, spherical tip | In distribution | |
| Cephalic screw ø10.5mm L100mm | In distribution | |
| Cardanic screwdriver long shaft, 3.5mm | In distribution | |
| Allen T-screwdriver, 5mm XXL | In distribution | |
| Eba One static cephalic screw ø10.5mm L110mm | In distribution | |
| Long nail ø13x400mm 130° right | In distribution | |
| Nails extractor | In distribution | |
| Trocar for stabilization wire, trocar tip | In distribution | |
| Long nail distal centering guide | In distribution | |
| Nails ruler kit with wire 800mm | In distribution | |
| Targeting device, XXL | In distribution | |
| Standard nail ø10x170mm 120° | In distribution | |
| Long nail ø11x340mm 130° right | In distribution | |
| Cephalic screw ø10.5mm L120mm | In distribution | |
| Eba One static cephalic screw ø10.5mm L115mm | In distribution | |
| Cephalic screwdriver | In distribution | |
| Long nail ø12x360mm 130° left | In distribution | |
| Long nail ø13x360mm 130° right | In distribution | |
| Cortical screw ø5.2mm L50mm | In distribution | |
| Long nail ø13x400mm 130° left | In distribution | |
| Eba One medium nail distal centering guide | In distribution | |
| Cephalic screw ø10.5mm L95mm | In distribution | |
| Cortical screw ø5.2mm L32.5mm | In distribution | |
| Nail connection bolt, Eba One carbon guide | In distribution | |
| Long nail ø11x280mm 130° left | In distribution | |
| Long nail ø10x340mm 130° left | In distribution | |
| Long nail ø12x320mm 130° right | In distribution | |
| Guide wire with olive ø2.5x800mm (STERILE) | In distribution | |
| Cephalic screw ø10.5mm L105mm | In distribution | |
| Standard nail ø10x170mm 130° | In distribution | |
| Cortical screw ø5.2mm L100mm | In distribution | |
| Cortical screw ø5.2mm L90mm | In distribution | |
| Instrument set tray, 1 empty | In distribution | |
| Cortical screw ø5.2mm L95mm | In distribution | |
| Cortical screw ø5.2mm L22.5mm | In distribution | |
| Eba One static cephalic screw ø10.5mm L75mm | In distribution | |
| Cortical screw ø5.2mm L47.5mm | In distribution | |
| Long nail ø10x340mm 130° right | In distribution | |
| Long nail ø12x400mm 130° right | In distribution | |
| Trocar for stabilization wire | In distribution | |
| Graduated drill bit, ø4.2x315mm (STERILE) | In distribution | |
| Cortical screw ø5.2mm L42.5mm | In distribution | |
| Cephalic screw ø10.5mm L85mm | In distribution | |
| Cortical screw ø5.2mm L70mm | In distribution | |
| Tissue protection sleeve | In distribution | |
| Diaphyseal cannula | In distribution | |
| Cephalic cannula, XXL | In distribution | |
| Long nail ø11x300mm 130° left | In distribution | |
| Long nail ø12x340mm 130° right | In distribution | |
| Cortical screw ruler | In distribution | |
| Long nail ø13x380mm 130° left | In distribution | |
| Cortical screw ø5.2mm L80mm | In distribution | |
| Cephalic screw ø10.5mm L125mm | In distribution | |
| Diaphyseal cannula, XXL | In distribution | |
| Standard nail ø11x170mm 120° | In distribution | |
| Long nail ø13x340mm 130° right | In distribution | |
| Diaphyseal trocar, XXL | In distribution | |
| Eba One static cephalic screw ø10.5mm L125mm | In distribution | |
| End cap 5mm | In distribution | |
| Impactor-extractor for guide EBA-5375 | In distribution | |
| Long nail ø10x320mm 130° right | In distribution | |
| Long nail ø12x340mm 130° left | In distribution | |
| Eba One static cephalic screw ø10.5mm L80mm | In distribution | |
| Instrument set tray, 4 empty | In distribution | |
| Diaphyseal trocar | In distribution | |
| Tissue protection sleeve, XXL | In distribution | |
| Long nail ø12x420mm 130° left | In distribution | |
| Graduated drill bit, ø4mm XXL | In distribution | |
| Long nail ø13x280mm 130° right | In distribution | |
| End cap 10mm | In distribution | |
| Long nail ø12x420mm 130° right | In distribution | |
| Long nail ø11x380mm 130° left | In distribution | |
| Long nail ø12x320mm 130° left | In distribution | |
| Targeting device, 130° | In distribution | |
| Cephalic screw ø10.5mm L110mm | In distribution | |
| Long nail ø13x360mm 130° left | In distribution | |
| Long nail ø11x320mm 130° left | In distribution | |
| Diaphyseal trocar, cannulated ø4.2mm | In distribution | |
| Long nail ø11x420mm 130° right | In distribution | |
| Instrument set tray, 2 empty | In distribution | |
| Cortical screw ø5.2mm L37.5mm | In distribution | |
| Cortical screw ø5.2mm L65mm | In distribution | |
| Cephalic screw ø10.5mm L70mm | In distribution | |
| Long nail ø12x280mm 130° left | In distribution | |
| Cephalic trocar | In distribution | |
| Cephalic cannula | In distribution | |
| Long nail ø11x380mm 130° right | In distribution | |
| Guide wire, threaded trocar tip ø3x410mm | In distribution | |
| Cortical screw ø5.2mm L25mm | In distribution | |
| Long nail ø10x420mm 130° right | In distribution | |
| Eba One medium nail distal centering guide | In distribution | |
| Long nail ø11x360mm 130° left | In distribution | |
| Long nail ø13x380mm 130° right | In distribution | |
| Long nail ø13x320mm 130° left | In distribution | |
| Diaphyseal trocar, cannulated | In distribution | |
| Eba One Targeting device, 120° | In distribution | |
| Diaphyseal drill | In distribution | |
| Instrument set tray, 3 empty | In distribution | |
| Cannulated reamer ø16mm, XXL | In distribution | |
| Cortical screw ø5.2mm L85mm | In distribution | |
| Cortical screw ø5.2mm L110mm | In distribution | |
| Eba One static cephalic screw ø10.5mm L100mm | In distribution | |
| Inserter | In distribution | |
| Eba One static cephalic screw ø10.5mm L95mm | In distribution | |
| Tap for cephalic screw | In distribution | |
| Long nail ø12x400mm 130° left | In distribution | |
| Long nail ø11x340mm 130° left | In distribution | |
| Eba One Targeting device, 125° | In distribution | |
| Eba One carbon targeting device | In distribution | |
| Cardanic screwdriver shaft, 3.5mm | In distribution | |
| Cephalic drill, XXL | In distribution | |
| Allen T-screwdriver, 5mm | In distribution | |
| Long nail ø12x300mm 130° right | In distribution | |
| Eba One static cephalic screw ø10.5mm L120mm | In distribution | |
| Nails ruler kit with wire 2.5x1000mm | In distribution | |
| Long nail ø12x280mm 130° right | In distribution | |
| Long nail ø10x280mm 130° right | In distribution | |
| Nails ruler kit with wire ø2,5x800mm | In distribution | |
| Eba One static cephalic screw ø10.5mm L85mm | In distribution | |
| Nails ruler, wire 800mm | In distribution | |
| Eba One medium nail ø11x230mm 130° | In distribution | |
| Long nail ø11x400mm 130° left | In distribution | |
| Cephalic trocar, trocar tip | In distribution | |
| Graduated drill bit, ø4mm | In distribution | |
| Flexible screwdriver, 3.5mm | In distribution | |
| Cephalic trocar, XXL | In distribution | |
| Cephalic drill | In distribution | |
| Obturator for trocar for stabilization wire | In distribution | |
| Cortical screw ø5.2mm L40mm | In distribution | |
| Standard nail ø11x170mm 125° | In distribution | |
| Cortical screw ø5.2mm L55mm | In distribution | |
| Eba One static cephalic screw ø10.5mm L130mm | In distribution | |
| Standard nail ø10x170mm 125° | In distribution | |
| Nails ruler kit with wire 1000mm | In distribution | |
| Cephalic screw ø10.5mm L130mm | In distribution | |
| Eba One static cephalic screw ø10.5mm L70mm | In distribution | |
| Cortical screw ø5.2mm L52.5mm | In distribution | |
| Guide wire, helical tip ø3x500mm | In distribution | |
| Cephalic screw ruler | In distribution | |
| Long nail ø13x420mm 130° right | In distribution | |
| Guide wire ø3x800mm (STERILE) | In distribution | |
| Cephalic screw ø10.5mm L75mm | 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.