Smartset
Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g
1manufacturer
3catalogue numbers in this listing
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 | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | MBB |
| Device type | Bone Cement, Antibiotic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K023012 |
| Record published | 2015-09-24 |
| Record revised | 2022-05-13 (version 6) |
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 |
| Storage | Storage environment temperature up to 25 °C; Handling environment temperature up to 25 °C |
| Packaging | Package of 10, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3092-040 | In distribution | |
| 5450-50-501 | In distribution | |
| 3092-020 | 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 |
| SpaceFlex Knee | G21 SRL | 3 |
Showing 12 of 44. All products under Bone Cement, Antibiotic
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2015-02-11 | Class II | Under Investigation by firm | One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated. This may result in surgical delays while a replacement package of cement is retrieved and mixed. | 1267 | 2015-05-19 |
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.