Dolphix
Temporary external fixation kit composed of: - Clamp with bone screw ø 6mm L160mm (2 pcs); - Clamps with transfixing bone screw ø5mm L220mm (1 pc); - Rod to rod clamp (2 pcs); - Rod ø12mm…
Temporary external fixation kit composed of: – Clamp with bone screw ø 6mm L160mm (2 pcs); – Clamps with transfixing bone screw ø5mm L220mm (1 pc); – Rod to rod clamp (2 pcs); – Rod ø12mm L200mm (1 pc); – Rod ø12mm L280mm (2 pcs); – Hand drill (1 pc). Bone screw material: titanium alloy Ti6Al4V ELI (ASTM F136).
9manufacturers in China registered for this device type
51catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Citieffe SRL, Italy |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K132363 |
| Record published | 2015-10-21 |
| Record revised | 2020-07-23 (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. |
| Sizes | Outer diameter 5 to 12 mm; length 150 to 400 mm |
| Distribution end date | 2018-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Clamp with SS bone screw ø5mm L180-40mm | In distribution | |
| SS bone screw ø4mm L120-30mm | In distribution | |
| Clamp with transfixing bone screw ø6mm L240mm | In distribution | |
| Box | In distribution | |
| Transfixing bone screw ø5mm L260mm | Outer Diameter 5 mm | In distribution |
| Clamp with SS bone screw ø5mm L180-40mm, Low Reflex | In distribution | |
| SS bone screw ø5mm L160-40mm | In distribution | |
| Clamp with bone screw ø5mm L180-40mm | In distribution | |
| Clamp with transfixing bone screw ø6mm L200mm | In distribution | |
| Bone screw ø5mm L180-40mm | In distribution | |
| Clamp with bone screw ø4mm L120-30mm | In distribution | |
| Bone screw ø6mm L200-45mm | In distribution | |
| SS Bone screw ø6mm L200-45mm | In distribution | |
| Clamp with transfixing bone screw ø6mm L220mm | In distribution | |
| SS Bone screw ø5mm L180-40mm, Low Reflex | In distribution | |
| Clamp with transfixing bone screw ø7mm L260mm | In distribution | |
| Transfixing bone screw ø5mm L240mm | Outer Diameter 5 mm | In distribution |
| Clamp with bone screw ø5mm L120mm | In distribution | |
| Transfixing bone screw ø5mm L200mm | Outer Diameter 5 mm | In distribution |
| Bone screw extension | In distribution | |
| Bone screw ø4mm L120-30mm | In distribution | |
| Clamp with bone screw ø5mm L180-40mm | In distribution | |
| Clamp with transfixing bone screw ø6mm L260mm | In distribution | |
| L-Shaped Rod ø12mm L100x300mm | L100x300mm | In distribution |
| Transfixing bone screw ø7mm L260mm | In distribution | |
| Omega-shaped Rod ø12mm L300mm – Drill brace | L200x300mm | In distribution |
| Transfixing bone screw ø5mm L220mm | Outer Diameter 5 mm | Withdrawn |
| Rod to rod clamp | Withdrawn | |
| Radiolucent rod ø12mm L200mm | Outer Diameter 12 mm | Withdrawn |
| Clamp for ø4mm bone screw | Withdrawn | |
| Clamp for ø6mm bone screw | Withdrawn | |
| Radiolucent rod ø12mm L150mm | Outer Diameter 12 mm | Withdrawn |
| Drill brace | Withdrawn | |
| Radiolucent rod ø12mm L300mm | Outer Diameter 12 mm | Withdrawn |
| Metatarsal accessory kit | Withdrawn | |
| Clamp with transfixing bone screw ø5mm L220mm | Withdrawn | |
| Radiolucent rod ø12mm L400mm | Outer Diameter 12 mm | Withdrawn |
| Drill bit | Withdrawn | |
| Transfixing bone screw ø6mm L260mm | Outer Diameter 6 mm | Withdrawn |
| Transfixing bone screw ø6mm L220mm | Outer Diameter 6 mm | Withdrawn |
| Clamp with bone screw ø6mm L200mm | Withdrawn | |
| Pilon fractures kit | Withdrawn | |
| Clamp for ø5mm bone screw | Withdrawn | |
| Transfixing bone screw ø6mm L240mm | Outer Diameter 6 mm | Withdrawn |
| U-Shaped Rod ø12mm | L200x300mm | Withdrawn |
| Clamp with bone screw ø6mm L160mm | Withdrawn | |
| Basic kit | Withdrawn | |
| Bone screw ø6mm L200mm | Outer Diameter 6 mm | Withdrawn |
| Soft tissue protection guide | Withdrawn | |
| Transfixing bone screw ø6mm L200mm | Outer Diameter 6 mm | Withdrawn |
| Bone screw ø6mm L160mm | Outer Diameter 6 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
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.