Zimmer
Zimmer PSIP
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Materialise NV, Belgium |
|---|---|
| FDA product code | MBV |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K140027 |
| Record published | 2017-02-10 |
| Record revised | 2022-02-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2019-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Zimmer PSIP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vanguard XP® Instrumentation | Biomet Orthopedics | 130 |
| Vanguard Complete Knee System | Biomet Orthopedics | 106 |
| Vanguard® 360 Instrument | Biomet Orthopedics | 98 |
| Biomet® Knee System | Biomet Orthopedics | 94 |
| Maxim Knee System | Biomet Orthopedics | 73 |
| Vanguard Knee System | Biomet Orthopedics | 49 |
| Vanguard Instrument | Biomet Orthopedics | 44 |
| Vanguard 360 Revision System | Biomet Orthopedics | 43 |
| Biomet® 360 | Biomet Orthopedics | 39 |
| Biomet® 360 Instrument | Biomet Orthopedics | 36 |
| Vanguard 360 | Biomet Orthopedics | 30 |
| Biomet 360 Knee System | Biomet Orthopedics | 27 |
Showing 12 of 41. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
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.