Smartset
SmartSet ENDURANCE MV Medium Viscosity Bone Cement 80g
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | KIH |
| Device type | Dispenser, Cement |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K033382 |
| Record published | 2015-09-24 |
| Record revised | 2020-06-19 (version 5) |
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 |
|---|---|---|
| 3102-080 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dispenser, Cement | Medtronic Sofamor Danek, Inc. | 14 |
| Pressurizer | Adler Ortho SpA | 11 |
| DJO Surgical | Encore Medical, L.P. | 7 |
| Vortex | Smith & Nephew, Inc. | 6 |
| Dispenser, Cement | Zimmer, Inc. | 5 |
| Miller™ | Zimmer, Inc. | 5 |
| Dispenser, Cement | Synthes (U.S.A.) LP | 5 |
| SpineJack | Stryker GmbH | 4 |
| Kyphon® Cement Delivery System | Medtronic Sofamor Danek, Inc. | 4 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 4 |
| PowerFlo | Zimmer, Inc. | 4 |
| Palamix® | Heraeus Medical LLC | 3 |
Showing 12 of 111. All products under Dispenser, Cement
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.