Palacos®
The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® R+G powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic…
The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® R+G powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
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 | Heraeus Medical LLC, United States |
|---|---|
| FDA product code | KIH |
| Device type | Dispenser, Cement |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K142157 |
| Record published | 2018-06-01 |
| Record revised | 2023-06-16 (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 |
| Packaging | Pallet of 108, paper carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R+G pro | 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.