Ilizarov Systems
1,5 MM DIA 300 MM Length ST. Steel Ilizarov Wire Cortical, Bayonet Point
9manufacturers in China registered for this device type
115catalogue 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 | Medicalplastic, Italy |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K994143 |
| Record published | 2016-10-27 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 5, pack of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 102101 | 20 | In distribution | |
| 102313 | 5 | In distribution | |
| 101902 | In distribution | ||
| 102550 | In distribution | ||
| 101501 | In distribution | ||
| 100500 | In distribution | ||
| 101502 | In distribution | ||
| 71013204 | In distribution | ||
| 201002 | In distribution | ||
| 100800 | In distribution | ||
| 100100 | In distribution | ||
| 101304 | In distribution | ||
| 100501 | In distribution | ||
| 71010705 | 5 | In distribution | |
| 201300 | In distribution | ||
| 201100 | In distribution | ||
| 102102 | 12 | In distribution | |
| 101900 | In distribution | ||
| 102301 | 5 | In distribution | |
| 100105 | In distribution | ||
| 100900 | In distribution | ||
| 101400 | In distribution | ||
| 101803 | In distribution | ||
| 102400 | 5 | In distribution | |
| 102600 | 20 | In distribution | |
| 101805 | In distribution | ||
| 100911 | In distribution | ||
| 101308 | In distribution | ||
| 103302 | In distribution | ||
| 71013000 | In distribution | ||
| 101801 | In distribution | ||
| 100250 | In distribution | ||
| 102402 | 5 | In distribution | |
| 102000 | In distribution | ||
| 201700 | 5 | In distribution | |
| 101309 | In distribution | ||
| 100910 | In distribution | ||
| 100901 | In distribution | ||
| 102401 | 5 | In distribution | |
| 101325 | In distribution | ||
| 102314 | 5 | In distribution | |
| 100112 | In distribution | ||
| 102312 | 5 | In distribution | |
| 101402 | In distribution | ||
| 101306 | In distribution | ||
| 101300 | In distribution | ||
| 100502 | In distribution | ||
| 101800 | In distribution | ||
| 100110 | In distribution | ||
| 101401 | In distribution | ||
| 100102 | In distribution | ||
| 101500 | In distribution | ||
| 101332 | In distribution | ||
| 101804 | In distribution | ||
| 101702 | In distribution | ||
| 100200 | In distribution | ||
| 101305 | In distribution | ||
| 102706 | 20 | In distribution | |
| 102302 | 5 | In distribution | |
| 100108 | In distribution | ||
| 102305 | 5 | In distribution | |
| 102101 | 12 | In distribution | |
| 100400 | In distribution | ||
| 100600 | In distribution | ||
| 101335 | In distribution | ||
| 101333 | In distribution | ||
| 100401 | In distribution | ||
| 101327 | In distribution | ||
| 102304 | 5 | In distribution | |
| 101301 | In distribution | ||
| 101700 | In distribution | ||
| 100601 | In distribution | ||
| 101901 | In distribution | ||
| 201008 | In distribution | ||
| 102707 | 20 | In distribution | |
| 102300 | 5 | In distribution | |
| 102107 | 10 | In distribution | |
| 102501 | In distribution | ||
| 101302 | In distribution | ||
| 100106 | In distribution | ||
| 100104 | In distribution | ||
| 102500 | In distribution | ||
| 101310 | In distribution | ||
| 100700 | In distribution | ||
| 102106 | 12 | In distribution | |
| 102107 | 12 | In distribution | |
| 71012502 | In distribution | ||
| 100503 | In distribution | ||
| 102701 | 20 | In distribution | |
| 101326 | In distribution | ||
| 101323 | In distribution | ||
| 101806 | In distribution | ||
| 102311 | 5 | In distribution | |
| 100107 | In distribution | ||
| 101810 | In distribution | ||
| 100402 | In distribution | ||
| 101807 | In distribution | ||
| 100101 | In distribution | ||
| 101600 | In distribution | ||
| 101317 | In distribution | ||
| 201006 | In distribution | ||
| 201004 | In distribution | ||
| 201201 | In distribution | ||
| 101307 | In distribution | ||
| 100111 | In distribution | ||
| 100103 | In distribution | ||
| 71013002 | In distribution | ||
| 102403 | 5 | In distribution | |
| 101802 | In distribution | ||
| 71012229 | 5 | In distribution | |
| 102303 | 5 | In distribution | |
| 101432 | In distribution | ||
| 102102 | 20 | In distribution | |
| 101303 | In distribution | ||
| 101602 | In distribution |
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 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
| gSource | Gsource, LLC. | 74 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
Recalls Naming This Product
19 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 208 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 124 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 474 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 735 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 552 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 452 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 176 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 147 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 51 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 27 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 42 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 91 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 328 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 813 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 933 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 503 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 513 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 41 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2009-01-23 | Not classified | Nonconforming Material/Component | Hinge failure: The product is cracking or breaking during use. | 7,089 units | 2013-07-29 |
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.