Masterloc Femoral Stems
Masterloc Cementless Ti Coated STD Stem # 4
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Medacta International SA, Switzerland |
|---|---|
| FDA product code | LZY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K151531 |
| Record published | 2015-11-04 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| 01.39.004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endohead | Medacta International SA | 51 |
| Quadra P femoral stems | Medacta International SA | 27 |
| Tandem | Smith & Nephew, Inc. | 24 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Depuy Orthopaedics, Inc. | 21 |
| B-P Total HIP System | Endotec, Inc. | 20 |
| Balance Microplasty HIP System | Biomet Orthopedics | 6 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Smith & Nephew, Inc. | 4 |
| Sirius® Hip System | Biomet Orthopedics | 3 |
| Taperloc Microplasty HIP System | Biomet Orthopedics | 3 |
| Sirius | Biomet Orthopedics | 3 |
| Balance HIP System | Biomet Orthopedics | 3 |
| Cureguard | Jiangsu Cureguard Glove Co., Ltd. | 1 |
Showing 12 of 13. All products under Prosthesis, Hip, Hemi-, Femoral, Metal Ball
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111145 | 2011-08-16 |
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.