Large Qwix
The Fixation screw is a cannulated titanium alloy screw of 5.5mm diameters partially threaded and decreased thread at the head, allowing optimal compression. The screw has a self-drilling…
The Fixation screw is a cannulated titanium alloy screw of 5.5mm diameters partially threaded and decreased thread at the head, allowing optimal compression. The screw has a self-drilling and self-tapping screw tip. These features enable its use in totally intra-osseous fixation. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile.
31manufacturers in China registered for this device type
57catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Newdeal Sas, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K050346 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 111530SND | 5.5mm diam. x 30mm length | In distribution |
| 121575SND | 5.5mm diam. x 75mm length | In distribution |
| 121540SND | 5.5mm diam. x 40mm length | In distribution |
| 111570SND | 5.5mm diam. x 70mm length | In distribution |
| 111795SND | 7.5mm diam. x 95mm length | In distribution |
| 111790SND | 7.5mm diam. x 90mm length | In distribution |
| 111770SND | 7.5mm diam. x 70mm length | In distribution |
| 121545SND | 5.5mm diam. x 45mm length | In distribution |
| 121535SND | 5.5mm diam. x 35mm length | In distribution |
| 111755SND | 7.5mm diam. x 55mm length | In distribution |
| 111580SND | 5.5mm diam. x 80mm length | In distribution |
| 111775SND | 7.5mm diam. x 75mm length | In distribution |
| 121790SND | 7.5mm diam. x 90mm length | In distribution |
| 121550SND | 5.5mm diam. x 50mm length | In distribution |
| 111780SND | 7.5mm diam. x 80mm length | In distribution |
| 121805SND | 7.5mm diam. x 105mm length | In distribution |
| 121780SND | 7.5mm diam. x 80mm length | In distribution |
| 111785SND | 7.5mm diam. x 85mm length | In distribution |
| 111550SND | 5.5mm diam. x 50mm length | In distribution |
| 111820SND | 7.5mm diam. x 120mm length | In distribution |
| 111565SND | 5.5mm diam. x 65mm length | In distribution |
| 111750SND | 7.5mm diam. x 50mm length | In distribution |
| 111815SND | 7.5mm diam. x 115mm length | In distribution |
| 111800SND | 7.5mm diam. x 100mm length | In distribution |
| 121755SND | 7.5mm diam. x 55mm length | In distribution |
| 111535SND | 5.5mm diam. x 35mm length | In distribution |
| 121580SND | 5.5mm diam. x 80mm length | In distribution |
| 111740SND | 7.5mm diam. x 40mm length | In distribution |
| 111560SND | 5.5mm diam. x 60mm length | In distribution |
| 121740SND | 7.5mm diam. x 40mm length | In distribution |
| 121795SND | 7.5mm diam. x 95mm length | In distribution |
| 121750SND | 7.5mm diam. x 50mm length | In distribution |
| 111805SND | 7.5mm diam. x 105mm length | In distribution |
| 111540SND | 5.5mm diam. x 40mm length | In distribution |
| 111810SND | 7.5mm diam. x 110mm length | In distribution |
| 121800SND | 7.5mm diam. x 100mm length | In distribution |
| 111575SND | 5.5mm diam. x 75mm length | In distribution |
| 121745SND | 7.5mm diam. x 45mm length | In distribution |
| 121560SND | 5.5mm diam. x 60mm length | In distribution |
| 121770SND | 7.5mm diam. x 70mm length | In distribution |
| 121785SND | 7.5mm diam. x 85mm length | In distribution |
| 121815SND | 7.5mm diam. x 115mm length | In distribution |
| 121775SND | 7.5mm diam. x 75mm length | In distribution |
| 121820SND | 7.5mm diam. x 120mm length | In distribution |
| 111765SND | 7.5mm diam. x 65mm length | In distribution |
| 121810SND | 7.5mm diam. x 110mm length | In distribution |
| 111760SND | 7.5mm diam. x 60mm length | In distribution |
| 111545SND | 5.5mm diam. x 45mm length | In distribution |
| 121570SND | 5.5mm diam. x 70mm length | In distribution |
| 121530SND | 5.5mm diam. x 30mm length | In distribution |
| 121765SND | 7.5mm diam. x 65mm length | In distribution |
| 121565SND | 5.5mm diam. x 65mm length | In distribution |
| 121555SND | 5.5mm diam. x 55mm length | In distribution |
| 111745SND | 7.5mm diam. x 45mm length | In distribution |
| 121760SND | 7.5mm diam. x 60mm length | In distribution |
| 111555SND | 5.5mm diam. x 55mm length | In distribution |
| QWX57INSTSET | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071639 | 2007-07-09 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2016-07-21 | Class II | Labeling mix-ups | Labeling on the Qwix Screw product states that it is a “compression screw” instead of a “positioning screw”. | 120 units from multiple lots | 2017-03-29 |
| Integra Lifesciences Corporation | 510(k) number | 2010-02-08 | Not classified | Labeling mix-ups | The screws were etched incorrectly as 34mm instead of the correct 32mm. | 2011-10-27 | |
| Integra Lifesciences Corporation | 510(k) number | 2010-02-08 | Not classified | Labeling mix-ups | The screws were etched incorrectly as 32mm instead of the correct 34mm length. | 2011-10-27 | |
| Integra Lifesciences Corporation | 510(k) number | 2008-02-27 | Not classified | Labeling mix-ups | Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length. | 42 units | 2008-08-21 |
| Integra Lifesciences Corporation | 510(k) number | 2008-02-27 | Not classified | Labeling mix-ups | Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length. | 20 units | 2008-08-21 |
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.