ZipFix
Sternal Zipfix With Needle Sterile / 5 Pack
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (2), Jiangsu (1). 3 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K110789 |
| Record published | 2015-09-14 |
| Record revised | 2023-01-16 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 08.501.001.20S | 20 | In distribution | |
| 08.501.001.01S | In distribution | ||
| 08.501.001.05S | 5 | In distribution | |
| 03.501.080 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cerclage, Fixation | Synthes Gmbh | 102 |
| Optilink | Synthes Gmbh | 61 |
| Songer® Spinal Cable System | Pioneer Surgical Technology, Inc. | 60 |
| DePuy Songer Spinal Cable System | Pioneer Surgical Technology, Inc. | 36 |
| Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 34 |
| Dall-Miles | Howmedica Osteonics Corp | 22 |
| Sternal Cable System | Pioneer Surgical Technology, Inc. | 20 |
| Sternal Cable System | A & E Medical Corporation | 19 |
| Compression Screw System | Biomet Orthopedics | 18 |
| Accord | Smith & Nephew, Inc. | 15 |
| Cable-Ready® | Zimmer, Inc. | 14 |
| Arthrex® | Arthrex, Inc. | 10 |
Showing 12 of 56. All products under Cerclage, Fixation
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2015-10-19 | Class II | Device Design | Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired in | 267 | 2016-08-26 |
| Synthes (USA) Products LLC | 510(k) number | 2015-07-22 | Class II | Device Design | The end cap may loosen and detach making the instrument non-functional. No injuries reported. | 451 | 2016-08-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-08-13 | Class II | Labeling False and Misleading | When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant. | 319 | 2016-08-18 |
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.