Dispenser, Cement
5 catalogue numbers from 5069-06, listed by Zimmer, Inc., United States, under Dispenser, Cement. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | KIH |
| Device type | Dispenser, Cement |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-01-31 |
| Record revised | 2023-05-03 (version 4) |
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 |
| Packaging | Pack of 1000 |
| Distribution end date | 2017-05-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5069-06 | In distribution | ||
| 31-8106-43 | In distribution | ||
| 5049-38 | 5 | In distribution | |
| 5069-62 | Withdrawn | ||
| 5069-61 | Withdrawn |
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 |
| 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 |
| Dispenser, Cement | Stryker GmbH | 3 |
Showing 12 of 111. All products under Dispenser, Cement
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K780266 | 1978-02-28 |
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.