Silktoe Spacer
10 catalogue numbers from SIZE 35 RIGHT, listed by BRM Extremities SRL, Italy, under Prosthesis, Toe, Constrained, Polymer. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
10catalogue 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 | BRM Extremities SRL, Italy |
|---|---|
| FDA product code | KWH |
| Device type | Prosthesis, Toe, Constrained, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3720 |
| Establishment | Manufacturer |
| 510(k) | K191966 |
| Record published | 2021-10-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Special Storage Condition, Specify: Store at room temperature, keep dry and away from humidity and direct sources of lig |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIZE 35 RIGHT | 35 RIGHT | In distribution |
| SIZE 35 LEFT | 35 LEFT | In distribution |
| SIZE 50 LEFT | 50 LEFT | In distribution |
| SIZE 40 RIGHT | 40 RIGHT | In distribution |
| SIZE 20 RIGHT | 20 RIGHT | In distribution |
| SIZE 20 LEFT | 20 LEFT | In distribution |
| SIZE 30 RIGHT | 30 RIGHT | In distribution |
| SIZE 50 RIGHT | 50 RIGHT | In distribution |
| SIZE 40 LEFT | 40 LEFT | In distribution |
| SIZE 30 LEFT | 30 LEFT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Profix | Smith & Nephew, Inc. | 138 |
| Sgarlato Silastic | Fusion Orthopedics, LLC | 51 |
| 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 |
| 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 |
|---|---|
| K191966 | 2020-02-13 |
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.