Dinamic T Humerus
Kit composed of: - Humeral nail ø7mm L200mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136).
17manufacturers in China registered for this device type
85catalogue 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) | K113387 |
| Record published | 2015-10-21 |
| 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 2.5 to 10 mm; length 6.8 to 320 mm |
| Distribution end date | 2016-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| End cap standard | In distribution | |
| Cannulated antegrade awl | In distribution | |
| Long nail ø7mm L220mm, right | Outer Diameter 10 mm | In distribution |
| Cephalic screw ø5mm L40mm | Length 40 mm | In distribution |
| Long nail ø7mm L260mm, left | Outer Diameter 10 mm | In distribution |
| Long nail ø7mm L240mm, left | Outer Diameter 10 mm | In distribution |
| Long nail impactor/extractor | In distribution | |
| ø5mm cannulated drill bit | In distribution | |
| Cephalic screw ø5mm L30mm | Length 30 mm | In distribution |
| End cap 4mm | Length 6.8 mm | In distribution |
| Instrument tray | In distribution | |
| ø2.5mmx450mm graduated guide wire | In distribution | |
| Cephalic screw ø5mm L55mm | Length 55 mm | In distribution |
| ø10mm cannulated flexible drill bit | In distribution | |
| Cephalic screw ø5mm L45mm | Length 42.5 mm | In distribution |
| Cephalic screw ø5mm L52.5mm | Length 52.5 mm | In distribution |
| Nail and screw ruler | In distribution | |
| Long nail ø7mm L320mm, left | Outer Diameter 10 mm | In distribution |
| Cephalic screw ø5mm L50mm | Length 50 mm | In distribution |
| Trocar | In distribution | |
| Cortical screw ø3.5mm L30mm | Length 30 mm | In distribution |
| Cephalic screw ø5mm L25mm | Length 25 mm | In distribution |
| Cortical screw ø3.5mm L40mm | Length 40 mm | In distribution |
| Cortical screw ø3.5mm L37.5mm | Length 37.5 mm | In distribution |
| Long nail ø7mm L300mm, left | Outer Diameter 10 mm | In distribution |
| Long nail ø7mm L320mm, right | Outer Diameter 10 mm | In distribution |
| Drill bit for screw removal | In distribution | |
| ø2.5mmx450mm graduated guide wire (sterile) | In distribution | |
| Cortical screw ø3.5mm L45mm | Length 45 mm | In distribution |
| Cephalic screw ø5mm L32.5mm | Length 32.5 mm | In distribution |
| Cortical screw ø3.5mm L27.5mm | Length 27.5 mm | In distribution |
| Hexagonal T Screwdriver | In distribution | |
| Long nail ø7mm L200mm, right | Outer Diameter 10 mm | In distribution |
| Trocar for ø2mm wire (out-nail screws) | In distribution | |
| End cap 8mm | Outer Diameter 9.7 mm | In distribution |
| Long nail ø7mm L260mm, right | Outer Diameter 10 mm | In distribution |
| Cortical screw ø3.5mm L20mm | Length 20 mm | In distribution |
| Nail extractor | In distribution | |
| Kirschner wire ø2.5mm L250mm | Outer Diameter 2.5 mm | In distribution |
| Cortical screw ø3.5mm L35mm | Length 35 mm | In distribution |
| Cortical screw ø3.5mm L17.5mm | Length 17.5 mm | In distribution |
| Soft tissue protection sleeve | In distribution | |
| ø9mm cannula | In distribution | |
| Quick-connect T handle | In distribution | |
| Cortical screw ø3.5mm L32.5mm | Length 32.5 mm | In distribution |
| ø7mmx200mm handle for scalpel | In distribution | |
| Long nail ø7mm L300mm, right | Outer Diameter 10 mm | In distribution |
| Graduated guide wire with olive ø2.5mmx450mm | In distribution | |
| Long nail ø7mm L220mm, left | Outer Diameter 10 mm | In distribution |
| Cephalic screw ø5mm L47.5mm | Length 47.5 mm | In distribution |
| Instrument tray for out-nail screws | In distribution | |
| Hexagonal screwdriver | In distribution | |
| Proximal guide | In distribution | |
| Long nail ø7mm L280mm, right | Outer Diameter 10 mm | In distribution |
| Cephalic screw ø5mm L42.5mm | Length 42.5 mm | In distribution |
| Cortical screw ø3.5mm L42.5mm | Length 42.5 mm | In distribution |
| Cephalic screw ø5mm L35mm | Length 35 mm | In distribution |
| Long nail ø7mm L280mm, left | Outer Diameter 10 mm | In distribution |
| Standard nail ø7mm L150mm | Outer Diameter 10 mm | In distribution |
| Cephalic screw ø5mm L27.5mm | Outer Diameter 5 mm | In distribution |
| Cortical screw ø3.5mm L22.5mm | Length 22.5 mm | In distribution |
| Cephalic screw ø5mm L37.5mm | Length 37.5 mm | In distribution |
| Cortical screw ø3.5mm L25mm | Length 25 mm | In distribution |
| Long nail ø7mm L200mm, left | Outer Diameter 10 mm | In distribution |
| Long nail ø7mm L240mm, right | Outer Diameter 10 mm | In distribution |
| Fracture alignment and guide wire exchange tool | In distribution | |
| Long nail distal guide | In distribution | |
| Cannulated drill bit,ø5mm, Hudson connection | In distribution | |
| Box for screws | In distribution | |
| Soft tissue protection sleeve for out-nail screws | In distribution | |
| Long nail ø7mm L200mm, right | Length 200 mm | Withdrawn |
| Long nail ø7mm L300mm, left | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L300mm, right | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L200mm, left | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L220mm, left | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L280mm, left | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L260mm, left | Outer Diameter 8 mm | Withdrawn |
| Standard nail ø7mm L150mm | Length 150 mm | Withdrawn |
| Long nail ø7mm L320mm, right | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L220mm, right | Right | Withdrawn |
| Long nail ø7mm L240mm, right | Right | Withdrawn |
| Long nail ø7mm L320mm, left | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L260mm, right | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L280mm, right | Outer Diameter 8 mm | Withdrawn |
| Long nail ø7mm L240mm, left | Outer Diameter 8 mm | Withdrawn |
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.