Estremo
Tissue protection sleeve with AO quick connection
17manufacturers in China registered for this device type
225catalogue 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) | K181540 |
| Record published | 2019-02-07 |
| Record revised | 2022-09-16 (version 6) |
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 |
| 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. |
| Distribution end date | 2021-02-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESTREMO nail ø13x425mm | In distribution | |
| Cortical screw ø5.2mm L55mm | In distribution | |
| ESTREMO nail ø11x200mm | In distribution | |
| Multihole trocar | In distribution | |
| Guide wire with olive ø3.2x800mm (STERILE) | In distribution | |
| Extractor, threaded M8x1 | In distribution | |
| Cannulated awl | In distribution | |
| Graduated drill bit, ø5.3mm | In distribution | |
| ESTREMO nail ø10x150mm Left | In distribution | |
| ESTREMO nail ø13x395mm | In distribution | |
| ESTREMO nail ø12x250mm Right | In distribution | |
| ESTREMO nail ø13x410mm | In distribution | |
| Allen T-screwdriver, 5mm, long | In distribution | |
| Cortical screw ø5.2mm L100mm | In distribution | |
| ESTREMO locking end cap, 5mm | In distribution | |
| ESTREMO nail ø12x150mm Right | In distribution | |
| Drill bit, ø4mm | In distribution | |
| Cannulated drill, ø5mm | In distribution | |
| ESTREMO nail ø12x150mm | In distribution | |
| ESTREMO nail ø8x380mm | In distribution | |
| ESTREMO nail ø11x300mm Left | In distribution | |
| ESTREMO nail ø12x410mm | In distribution | |
| Slotted hammer | In distribution | |
| ESTREMO instrument set tray, 2 empty | In distribution | |
| ESTREMO nail ø9x425mm | In distribution | |
| ESTREMO locking end cap | In distribution | |
| ESTREMO nail ø10x440mm | In distribution | |
| ESTREMO nail ø10x150mm | In distribution | |
| ESTREMO nail ø13x305mm | In distribution | |
| ESTREMO nail ø10x200mm Right | In distribution | |
| ESTREMO nail ø12x455mm | In distribution | |
| Talo-calcaneal compression cap | In distribution | |
| ESTREMO nail ø11x150mm | In distribution | |
| Cortical screw ø5.2mm L27.5mm | In distribution | |
| Cortical screw ø5.2mm L35mm | In distribution | |
| Cannulated reamer, ø12.5mm | In distribution | |
| Cortical screw ø5.2mm L47.5mm | In distribution | |
| ESTREMO nail ø11x250mm Left | In distribution | |
| Cannulated reamer, ø12.5mm | In distribution | |
| ESTREMO nail ø9x350mm | In distribution | |
| ESTREMO nail ø11x425mm | In distribution | |
| ESTREMO nail ø8x365mm | In distribution | |
| Graduated drill bit, ø5.3mm | In distribution | |
| ESTREMO nail ø9x260mm | In distribution | |
| ESTREMO nail ø10x470mm | In distribution | |
| Cannula with handle | In distribution | |
| Drill bit, ø4x110mm | In distribution | |
| ESTREMO nail ø12x380mm | In distribution | |
| ESTREMO guide | In distribution | |
| Cortical screw ø5.2mm L40mm | In distribution | |
| ESTREMO nail ø8x260mm | In distribution | |
| ESTREMO nail ø9x455mm | In distribution | |
| Allen T-wrench, 8mm | In distribution | |
| Drill bit, ø4x110mm (STERILE) | In distribution | |
| Tissue protection sleeve AO joint, suprapatellar | In distribution | |
| ESTREMO nail ø10x425mm | In distribution | |
| ESTREMO nail ø12x200mm Right | In distribution | |
| ESTREMO nail ø12x425mm | In distribution | |
| Trocar | In distribution | |
| ESTREMO nail ø11x320mm | In distribution | |
| ESTREMO nail ø11x260mm | In distribution | |
| Obturator with handle | In distribution | |
| ESTREMO nail ø9x365mm | In distribution | |
| ESTREMO nail ø12x275mm | In distribution | |
| ESTREMO nail ø9x470mm | In distribution | |
| ESTREMO nail ø10x250mm Left | In distribution | |
| ESTREMO nail ø10x200mm Left | In distribution | |
| ESTREMO nail ø12x440mm | In distribution | |
| Cortical screw ø5.2mm L37.5mm | In distribution | |
| ESTREMO nail ø13x260mm | In distribution | |
| ESTREMO instrument box, empty | In distribution | |
| ESTREMO nail ø8x290mm | In distribution | |
| ESTREMO nail ø10x335mm | In distribution | |
| Cortical screw ø5.2mm L110mm | In distribution | |
| ESTREMO nail ø8x335mm | In distribution | |
| Cortical screw ø4mm L40mm | In distribution | |
| Nails ruler kit with wire 800mm | In distribution | |
| ESTREMO nail ø12x150mm Left | In distribution | |
| ESTREMO nail ø11x380mm | In distribution | |
| ESTREMO instrument set tray, 3 empty | In distribution | |
| ESTREMO end cap, extra small | In distribution | |
| ESTREMO nail ø11x365mm | In distribution | |
| ESTREMO nail ø10x300mm Right | In distribution | |
| Graduated drill bit, ø4mm | In distribution | |
| ESTREMO instrument set tray ankle fusion, empty | In distribution | |
| ESTREMO nail ø10x275mm | In distribution | |
| ESTREMO nail ø8x395mm | In distribution | |
| ESTREMO nail ø11x410mm | In distribution | |
| Kirschner wire, trocar tip ø3x350mm | In distribution | |
| Screwdriver, 5mm Hudson coupling | In distribution | |
| Cortical screw ø5.2mm L32.5mm | In distribution | |
| Cortical screw ø5.2mm L80mm | In distribution | |
| Cannulated T-handle with Hudson coupling | In distribution | |
| Screwdriver, 5mm Hudson coupling, short | In distribution | |
| Cannulated drill, ø5mm | In distribution | |
| ESTREMO nail ø12x470mm | In distribution | |
| Template nails length | In distribution | |
| Guide wire with olive ø3x800mm | In distribution | |
| ESTREMO nail ø12x260mm | In distribution | |
| ESTREMO nail ø11x290mm | In distribution | |
| Screws depth gauge | In distribution | |
| ESTREMO nail ø11x440mm | In distribution | |
| ESTREMO nail ø11x350mm | In distribution | |
| ESTREMO instrument set tray generic, empty | In distribution | |
| Drill bit, ø4x350mm (STERILE) | In distribution | |
| ESTREMO nail ø9x305mm | In distribution | |
| Graduated drill bit, ø5.3mm | In distribution | |
| Guide wire with olive ø3x800mm | In distribution | |
| ESTREMO nail ø11x200mm Right | In distribution | |
| Fracture alignment guide wire exchange tool | In distribution | |
| ESTREMO nail ø12x300mm Left | In distribution | |
| Graduated drill bit, ø4mm | In distribution | |
| ESTREMO nail ø9x440mm | In distribution | |
| ESTREMO nail ø13x440mm | In distribution | |
| ESTREMO nail ø10x350mm | In distribution | |
| ESTREMO nail ø8x350mm | In distribution | |
| Nails ruler, wire 800mm | In distribution | |
| ESTREMO nail ø11x150mm Right | In distribution | |
| ESTREMO nail ø13x290mm | In distribution | |
| ESTREMO end cap, standard | In distribution | |
| ESTREMO guide | In distribution | |
| ESTREMO nail ø10x260mm | In distribution | |
| Femur-Tibia Collimate, ø10mm | In distribution | |
| ESTREMO nail ø13x350mm | In distribution | |
| Kirschner wire, trocar tip ø3x350mm | In distribution | |
| Graduated drill bit, ø5.3mm | In distribution | |
| ESTREMO nail ø12x350mm | In distribution | |
| ESTREMO nail ø9x395mm | In distribution | |
| Cortical screw ø5.2mm L30mm | In distribution | |
| ESTREMO nail ø12x250mm Left | In distribution | |
| ESTREMO nail ø11x150mm Left | In distribution | |
| Compaction device | In distribution | |
| ESTREMO nail ø10x395mm | In distribution | |
| Cortical screw ø5.2mm L45mm | In distribution | |
| T-handle with AO coupling | In distribution | |
| Cortical screw ø5.2mm L25mm | In distribution | |
| ESTREMO nail ø11x335mm | In distribution | |
| Cortical screw ø5.2mm L42.5mm | In distribution | |
| ESTREMO end cap, medium | In distribution | |
| ESTREMO targeting device distal femur antegrade | In distribution | |
| Cortical screw ø4mm L35mm | In distribution | |
| ESTREMO inserter, tibia parapatellar | In distribution | |
| ESTREMO nail ø9x380mm | In distribution | |
| Screws ruler | In distribution | |
| Cortical screw ø5.2mm L75mm | In distribution | |
| ESTREMO nail ø13x335mm | In distribution | |
| ESTREMO nail ø8x320mm | In distribution | |
| ESTREMO instrument set tray supra+retro, empty | In distribution | |
| ESTREMO nail ø10x410mm | In distribution | |
| ESTREMO nail ø10x200mm | In distribution | |
| Cannulated reamer, ø12.5mm | In distribution | |
| Allen T-screwdriver, 5mm, short | In distribution | |
| Cortical screw ø4mm L30mm | In distribution | |
| Multihole trocar ø13mm, suprapatellar | In distribution | |
| Fracture alignment guide wire exchange tool | In distribution | |
| ESTREMO guide, proximal femur antegrade | In distribution | |
| Cortical screw ø4mm L25mm | In distribution | |
| Cannulated drill, ø5mm | In distribution | |
| Cortical screw ø5.2mm L90mm | In distribution | |
| ESTREMO locking end cap, 10mm | In distribution | |
| ESTREMO nail ø12x305mm | In distribution | |
| ESTREMO nail ø10x305mm | In distribution | |
| Cortical screw ø5.2mm L70mm | In distribution | |
| Cortical screw ø5.2mm L65mm | In distribution | |
| Cortical screw ø4mm L20mm | In distribution | |
| ESTREMO nail ø11x250mm Right | In distribution | |
| Compaction device | In distribution | |
| Estremo Ankle ruler kit with guide wire ø2.5x800mm | In distribution | |
| ESTREMO nail ø12x290mm | In distribution | |
| ESTREMO nail ø12x365mm | In distribution | |
| Cortical screw ø5.2mm L105mm | In distribution | |
| Chuck for ø2,5-3mm wires | In distribution | |
| ESTREMO end cap, 5mm | In distribution | |
| ESTREMO nail ø10x290mm | In distribution | |
| ESTREMO nail ø11x305mm | In distribution | |
| ESTREMO ankle fusion guide | In distribution | |
| Cortical screw ø5.2mm L52.5mm | In distribution | |
| ESTREMO nail ø11x395mm | In distribution | |
| Screws depth gauge | In distribution | |
| ESTREMO nail ø10x380mm | In distribution | |
| ESTREMO nail ø9x275mm | In distribution | |
| ESTREMO targeting device | In distribution | |
| ESTREMO nail ø9x335mm | In distribution | |
| ESTREMO nail ø9x320mm | In distribution | |
| ESTREMO nail ø13x320mm | In distribution | |
| ESTREMO nail ø11x470mm | In distribution | |
| ESTREMO nail ø11x455mm | In distribution | |
| ESTREMO nail ø12x300mm Right | In distribution | |
| ESTREMO nail ø12x335mm | In distribution | |
| ESTREMO nail ø9x410mm | In distribution | |
| ESTREMO nail ø10x455mm | In distribution | |
| Cortical screw ø5.2mm L85mm | In distribution | |
| ESTREMO nail ø13x380mm | In distribution | |
| Cortical screw ø5.2mm L60mm | In distribution | |
| ESTREMO nail ø11x300mm Right | In distribution | |
| ESTREMO nail ø13x365mm | In distribution | |
| ESTREMO nail ø12x200mm | In distribution | |
| ESTREMO nail ø12x395mm | In distribution | |
| Graduated drill bit, ø4mm | In distribution | |
| Cortical screw ø5.2mm L50mm | In distribution | |
| Cortical screw ø5.2mm L95mm | In distribution | |
| ESTREMO nail ø11x275mm | In distribution | |
| ESTREMO nail ø13x455mm | In distribution | |
| Screwdriver, 2.5mm AO coupling | In distribution | |
| ESTREMO nail ø10x150mm Right | In distribution | |
| ESTREMO nail ø8x275mm | In distribution | |
| Impaction bolt, cannulated | In distribution | |
| Nails ruler kit with wire 1000mm | In distribution | |
| ESTREMO nail ø11x200mm Left | In distribution | |
| ESTREMO nail ø12x320mm | In distribution | |
| ESTREMO nail ø10x250mm Right | In distribution | |
| Drill bit, ø4mm | In distribution | |
| Cannula | In distribution | |
| Trocar for drill bit ø4mm | In distribution | |
| ESTREMO end cap, 10mm | In distribution | |
| ESTREMO nail ø8x305mm | In distribution | |
| ESTREMO nail ø10x320mm | In distribution | |
| ESTREMO nail ø9x290mm | In distribution | |
| ESTREMO nail ø10x300mm Left | In distribution | |
| ESTREMO nail ø13x470mm | In distribution | |
| ESTREMO nail ø13x275mm | In distribution | |
| Allen wrench, 5mm | In distribution | |
| ESTREMO nail ø10x365mm | In distribution | |
| ESTREMO nail ø12x200mm Left | In distribution | |
| Cortical screw ø5.2mm L22.5mm | 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.