Sgarlato Silastic
GAIT Broach (Diamond) Proximal
4manufacturers in China registered for this device type
51catalogue numbers in this listing
1510(k) clearance
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 | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | KWH |
| Device type | Prosthesis, Toe, Constrained, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3720 |
| Record published | 2020-11-20 |
| Record revised | 2023-06-14 (version 3) |
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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-200-03 | In distribution | |
| 90-301-25 | In distribution | |
| 30-099-01 | In distribution | |
| 70-100-02 | In distribution | |
| 90-099-01 | In distribution | |
| 30-301-52-S | In distribution | |
| 70-095-01 | In distribution | |
| 30-099-02 | In distribution | |
| 80-100-02 | In distribution | |
| 90-099-01 | In distribution | |
| 30-200-02 | In distribution | |
| 90-301-23-S | In distribution | |
| 30-100-03 | In distribution | |
| 30-301-51-S | In distribution | |
| 70-098-01 | In distribution | |
| 30-100-01 | In distribution | |
| 90-301-23 | In distribution | |
| 70-099-01 | In distribution | |
| 30-099-03 | In distribution | |
| 30-300-02-S | In distribution | |
| 30-301-02 | In distribution | |
| 80-099-01 | In distribution | |
| 90-301-20 | In distribution | |
| 90-100-02 | In distribution | |
| 70-098-01 | In distribution | |
| 90-099-02 | In distribution | |
| 90-301-20-S | In distribution | |
| 90-301-25-S | In distribution | |
| 80-099-INST | In distribution | |
| 30-300-01 | In distribution | |
| 30-100-02 | In distribution | |
| 90-100-03 | In distribution | |
| 70-099-02 | In distribution | |
| 80-100-01 | In distribution | |
| 30-301-51 | In distribution | |
| 70-095-01-S | In distribution | |
| 30-301-52 | In distribution | |
| 80-099-02 | In distribution | |
| 90-099-INST | In distribution | |
| 30-301-01 | In distribution | |
| 80-100-03 | In distribution | |
| 90-099-03 | In distribution | |
| 70-097-01 | In distribution | |
| 90-100-01 | In distribution | |
| TN-SG-1000 | In distribution | |
| 90-099-03 | In distribution | |
| 30-300-02 | In distribution | |
| 70-099-INST | In distribution | |
| 70-098-02 | In distribution | |
| 70-100-01 | In distribution | |
| 90-099-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Profix | Smith & Nephew, Inc. | 138 |
| Swanson | Wright Medical Technology, Inc. | 29 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190136 | 2019-10-21 |
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.