GMK Uni
Anatomical Femoral Component Cemented #5 LM/RL
6manufacturers in China registered for this device type
82catalogue 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 | Medacta International SA, Switzerland |
|---|---|
| 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, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2021-10-25 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02.08.IF3.09.LMRL | In distribution | |
| 02.08.IF5.09.RMLL | In distribution | |
| 02.08.305LMRL | In distribution | |
| 02.08.IF5.12.RMLL | In distribution | |
| 02.08.IF5.08.LMRL | In distribution | |
| 02.08.IF4.09.RMLL | In distribution | |
| 02.08.IF2.09.LMRL | In distribution | |
| 02.08.TF25.RMLL | In distribution | |
| 02.08.TF22.RMLL | In distribution | |
| 02.08.IF1.08.RMLL | In distribution | |
| 02.08.TF23.RMLL | In distribution | |
| 02.08.IF1.06.RMLL | In distribution | |
| 02.08.IF5.06.RMLL | In distribution | |
| 02.08.303LMRL | In distribution | |
| 02.08.IF3.06.RMLL | In distribution | |
| 02.08.TF22.LMRL | In distribution | |
| 02.08.IF4.08.RMLL | In distribution | |
| 02.08.IF2.09.RMLL | In distribution | |
| 02.08.TF21.LMRL | In distribution | |
| 02.08.IF3.10.RMLL | In distribution | |
| 02.08.IF5.09.LMRL | In distribution | |
| 02.08.IF3.08.LMRL | In distribution | |
| 02.08.IF3.12.LMRL | In distribution | |
| 02.08.TF25.LMRL | In distribution | |
| 02.08.IF4.09.LMRL | In distribution | |
| 02.08.TF24.LMRL | In distribution | |
| 02.08.IF2.08.RMLL | In distribution | |
| 02.08.IF4.06.LMRL | In distribution | |
| 02.08.IF5.10.RMLL | In distribution | |
| 02.08.TF24.RMLL | In distribution | |
| 02.08.IF5.08.RMLL | In distribution | |
| 02.08.IF1.09.RMLL | In distribution | |
| 02.08.IF4.12.RMLL | In distribution | |
| 02.08.IF4.12.LMRL | In distribution | |
| 02.08.IF2.06.LMRL | In distribution | |
| 02.08.300RMLL | In distribution | |
| 02.08.IF5.06.LMRL | In distribution | |
| 02.08.IF1.07.LMRL | In distribution | |
| 02.08.305RMLL | In distribution | |
| 02.08.IF1.07.RMLL | In distribution | |
| 02.08.IF4.06.RMLL | In distribution | |
| 02.08.IF1.12.RMLL | In distribution | |
| 02.08.301LMRL | In distribution | |
| 02.08.IF3.09.RMLL | In distribution | |
| 02.08.302LMRL | In distribution | |
| 02.08.IF3.12.RMLL | In distribution | |
| 02.08.IF4.10.RMLL | In distribution | |
| 02.08.IF1.09.LMRL | In distribution | |
| 02.08.IF2.10.RMLL | In distribution | |
| 02.08.IF1.08.LMRL | In distribution | |
| 02.08.IF2.12.LMRL | In distribution | |
| 02.08.IF4.07.RMLL | In distribution | |
| 02.08.IF1.10.LMRL | In distribution | |
| 02.08.IF5.12.LMRL | In distribution | |
| 02.08.IF2.12.RMLL | In distribution | |
| 02.08.IF3.08.RMLL | In distribution | |
| 02.08.IF1.06.LMRL | In distribution | |
| 02.08.IF3.10.LMRL | In distribution | |
| 02.08.IF4.08.LMRL | In distribution | |
| 02.08.IF4.10.LMRL | In distribution | |
| 02.08.IF5.07.RMLL | In distribution | |
| 02.08.IF3.07.RMLL | In distribution | |
| 02.08.IF2.08.LMRL | In distribution | |
| 02.08.IF2.07.LMRL | In distribution | |
| 02.08.302RMLL | In distribution | |
| 02.08.TF23.LMRL | In distribution | |
| 02.08.IF2.10.LMRL | In distribution | |
| 02.08.304RMLL | In distribution | |
| 02.08.300LMRL | In distribution | |
| 02.08.IF3.07.LMRL | In distribution | |
| 02.08.IF1.10.RMLL | In distribution | |
| 02.08.301RMLL | In distribution | |
| 02.08.304LMRL | In distribution | |
| 02.08.IF1.12.LMRL | In distribution | |
| 02.08.IF5.07.LMRL | In distribution | |
| 02.08.303RMLL | In distribution | |
| 02.08.TF21.RMLL | In distribution | |
| 02.08.IF3.12.RMLL | In distribution | |
| 02.08.IF4.07.LMRL | In distribution | |
| 02.08.IF2.07.RMLL | In distribution | |
| 02.08.IF2.06.RMLL | In distribution | |
| 02.08.IF5.10.LMRL | 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.