Cemex Genta System Fast 70g
Cemex Genta System Fast 70g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 70g holds the powder (70g) and liquid (29,3g) components separately within a…
Cemex Genta System Fast 70g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 70g holds the powder (70g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex Genta System Fast 70g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Tecres SPA, Italy |
|---|---|
| FDA product code | MBB |
| Device type | Bone Cement, Antibiotic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Record published | 2015-10-07 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13A2101 US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remedy Spacer | Osteoremedies, LLC | 28 |
| CeMend Shoulder Spacer Mold | G21 SRL | 12 |
| Palacos® | Heraeus Medical LLC | 8 |
| StageOne™ | Biomet Orthopedics | 8 |
| SpaceFlex Shoulder | G21 SRL | 6 |
| Interspace Tapered Wedge Stem | Tecres SPA | 6 |
| InterSpace Hip | Tecres SPA | 6 |
| Surespace | Ortho Development Corp. | 5 |
| Prostalac | Depuy Orthopaedics, Inc. | 4 |
| CeMend Shoulder Spacer | G21 SRL | 4 |
| Rally | Smith & Nephew, Inc. | 3 |
| Smartset | Depuy (Ireland) | 3 |
Showing 12 of 44. All products under Bone Cement, Antibiotic
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.