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).
17manufacturers in China registered for this device type
53catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Citieffe SRL, Italy |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K132363 |
| Record published | 2018-10-17 |
| Record revised | 2020-07-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 650 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Clamp with SS bone screw ø6mm L200-45mm | In distribution | |
| Clamp for ø4mm bone screw | In distribution | |
| Clamp with bone screw ø6mm L200mm | In distribution | |
| Delta kit – Titanium | In distribution | |
| Radiolucent rod ø12mm L500mm | Length 500 mm | In distribution |
| Metatarsal kit – Titanium | In distribution | |
| Bone screw ø5mm L180-40mm | In distribution | |
| SS Bone screw ø4mm L120-30mm, Low Reflex | In distribution | |
| Clamp with bone screw ø6mm L200-45mm | In distribution | |
| Clamp with SS bone screw ø4mm L120-30mm | In distribution | |
| Soft tissue protection guide | In distribution | |
| Clamp with bone screw ø6mm L160mm | In distribution | |
| Drill bit | In distribution | |
| Rod to rod clamp | In distribution | |
| Transfixing bone screw ø6mm L200mm | Length 200 mm | In distribution |
| Dolphix Distractor-compactor, L | In distribution | |
| Bone screw ø6mm L160mm | Length 160 mm | In distribution |
| Bone screw ø6mm L200-45mm | In distribution | |
| Clamp with bone screw ø4mm L120-30mm | In distribution | |
| Pilon fractures kit | In distribution | |
| Universal kit – Titanium | In distribution | |
| L-Shaped Rod ø12mm L70x250mm | In distribution | |
| Dolphix fixator L-Rod field Kit diaphyseal | In distribution | |
| Transfixing bone screw ø5mm L220mm | Length 220 mm | In distribution |
| Transfixing bone screw ø6mm L220mm | Length 220 mm | In distribution |
| Clamp with SS bone screw ø6mm L200-45mm, Low Reflex | In distribution | |
| Radiolucent rod ø12mm L650mm | Length 650 mm | In distribution |
| Starter kit – St. Steel | In distribution | |
| Clamp for ø6mm bone screw | In distribution | |
| SS Bone screw ø6mm L200-45mm, Low Reflex | In distribution | |
| Starter kit – Titanium | In distribution | |
| Radiolucent rod ø12mm L280mm | Length 280 mm | In distribution |
| Radiolucent rod ø12mm L600mm | Length 600 mm | In distribution |
| Bone screw ø4mm L120-30mm | In distribution | |
| Transfixing bone screw ø6mm L260mm | Length 260 mm | In distribution |
| U-Shaped Rod ø12mm | Outer Diameter 12 mm | In distribution |
| Transfixing bone screw ø6mm L240mm | Length 240 mm | In distribution |
| Clamp with transfixing bone screw ø5mm L220mm | In distribution | |
| Basic kit | In distribution | |
| Drill brace | In distribution | |
| Bone screw ø6mm L200mm | Length 200 mm | In distribution |
| Metatarsal accessory kit | In distribution | |
| Radiolucent rod ø12mm L200mm | Length 200 mm | In distribution |
| Radiolucent rod ø12mm L150mm | Length 150 mm | In distribution |
| Dolphix cable ties (4 pcs) | In distribution | |
| Clamp with bone screw ø6mm L200-45mm | In distribution | |
| Clamp for ø5mm bone screw | In distribution | |
| SS bone screw ø5mm L180-40mm | In distribution | |
| Clamp with SS bone screw ø5mm L160-40mm | In distribution | |
| Radiolucent rod ø12mm L400mm | Length 400 mm | In distribution |
| Clamp with SS bone screw ø4mm L120-30mm, Low Reflex | In distribution | |
| Radiolucent rod ø12mm L300mm | Length 300 mm | In distribution |
| Dolphix Velcro Security Wrao (10 pcs) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113384 | 2012-05-01 |
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.