U-KneeTec
Posterior condyle cutting guide S4 Med L/Lat R
6manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Corin Limited, United Kingdom |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K120262 |
| Record published | 2018-08-28 |
| Record revised | 2023-05-03 (version 2) |
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 |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MVV653 | In distribution | |
| MVV612 | In distribution | |
| MVV701 | In distribution | |
| MVV702 | In distribution | |
| GDU701 | In distribution | |
| MVV634 | In distribution | |
| MVV656 | In distribution | |
| MVV711 | In distribution | |
| MVV624 | In distribution | |
| MVV620 | In distribution | |
| MVV659 | In distribution | |
| MVV713 | In distribution | |
| MDF930 | In distribution | |
| MVV654 | In distribution | |
| MVV673 | In distribution | |
| MVV704 | In distribution | |
| MDF931 | In distribution | |
| MVV665 | In distribution | |
| MVV614 | In distribution | |
| GDU700 | In distribution | |
| MVV700 | In distribution | |
| GDU703 | In distribution | |
| MVV602 | In distribution | |
| MVV613 | In distribution | |
| MVV651 | In distribution | |
| MVV667 | In distribution | |
| MVV631 | In distribution | |
| MVV642 | In distribution | |
| MVV671 | In distribution | |
| MVV603 | In distribution | |
| GDU704 | In distribution | |
| MVV655 | In distribution | |
| MVV652 | In distribution | |
| MVV664 | In distribution | |
| MDU702 | In distribution | |
| MVV622 | In distribution | |
| MVV712 | In distribution | |
| MVV601 | In distribution | |
| MVV621 | In distribution | |
| MVV644 | In distribution | |
| MVV640 | In distribution | |
| MVV670 | In distribution | |
| MVV666 | In distribution | |
| MVV641 | In distribution | |
| GDU702 | In distribution | |
| MVV714 | In distribution | |
| MVV661 | In distribution | |
| MVV632 | In distribution | |
| MVV672 | In distribution | |
| MVV630 | In distribution | |
| MDU907 | In distribution | |
| MVV643 | In distribution | |
| MVV611 | In distribution | |
| MVV650 | In distribution | |
| MVV710 | In distribution | |
| MVV623 | In distribution | |
| MVV703 | In distribution | |
| MVV633 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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.