Swanson
Flexspan Flexible Hinge Toe w/Grommets
4manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Zhejiang (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 |
|---|---|---|---|---|
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | KWH |
| Device type | Prosthesis, Toe, Constrained, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-15 |
| Record revised | 2025-03-06 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4260020 | Size: 2-0 | In distribution |
| 431001W | Size: 1 | In distribution |
| G4260103 | Size: #3S | In distribution |
| G4260105 | Size: #5S | In distribution |
| 4260060 | Size: 6-0 | In distribution |
| G4260010 | Size: #0 | In distribution |
| 4510002 | Size: 2 | In distribution |
| 431001L | Size: 1 | In distribution |
| 4260070 | Size: 7-0 | In distribution |
| G4260004 | Size: 4 | In distribution |
| G4260104 | Size: #4S | In distribution |
| 4260040 | Size: 4-0 | In distribution |
| 4260007 | Size: 7 | In distribution |
| G4260001 | Size: 1 | In distribution |
| 4260050 | Size: 5-0 | In distribution |
| 4310002 | Size: 2 | In distribution |
| G4260003 | Size: 3 | In distribution |
| G4260101 | Size: #1S | In distribution |
| G4260102 | Size: #2S | In distribution |
| G4260005 | Size: 5 | In distribution |
| G4260110 | Size: #0S | In distribution |
| 4310001 | Size: 1 | In distribution |
| G4260002 | Size: 2 | In distribution |
| 431002L | Size: 2 | In distribution |
| 431002S | Size: 2 | In distribution |
| 4260030 | Size: 3-0 | In distribution |
| 431001S | Size: 1 | In distribution |
| 4510001 | Size: 1 | In distribution |
| 4260006 | Size: 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Profix | Smith & Nephew, Inc. | 138 |
| Sgarlato Silastic | Fusion Orthopedics, LLC | 51 |
| Integra® | Ascension Orthopedics, Inc. | 16 |
| Silicone Toe System | Smith & Nephew, Inc. | 13 |
| RTS | IN2BONES USA, LLC | 10 |
| Ascent Knee System | Biomet Orthopedics | 10 |
| Silktoe Spacer | BRM Extremities SRL | 10 |
| Taperloc Complete Micro Primary Femoral | Biomet Orthopedics | 7 |
| OsteoMed | Osteomed | 6 |
| Futura™ FDI | Tornier Inc. | 6 |
| Futura™ CGT | Tornier Inc. | 5 |
| Orthoflex | Wright Medical Technology, Inc. | 4 |
Showing 12 of 14. All products under Prosthesis, Toe, Constrained, Polymer
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.