Endohead
Medacta Endo Head Ø 45, M
5manufacturers in China registered for this device type
51catalogue numbers in this listing
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) | K111145 |
| Record published | 2014-11-18 |
| Record revised | 2020-09-09 (version 4) |
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 |
|---|---|---|
| 01.25.245M | In distribution | |
| 01.25.252M | In distribution | |
| 01.25.252L | In distribution | |
| 01.25.241L | In distribution | |
| 01.25.256M | In distribution | |
| 01.25.250S | In distribution | |
| 01.25.248M | In distribution | |
| 01.25.253M | In distribution | |
| 01.25.244L | In distribution | |
| 01.25.251M | In distribution | |
| 01.25.250L | In distribution | |
| 01.25.242S | In distribution | |
| 01.25.245L | In distribution | |
| 01.25.241M | In distribution | |
| 01.25.255L | In distribution | |
| 01.25.254L | In distribution | |
| 01.25.240S | In distribution | |
| 01.25.248S | In distribution | |
| 01.25.253L | In distribution | |
| 01.25.247S | In distribution | |
| 01.25.242L | In distribution | |
| 01.25.247M | In distribution | |
| 01.25.250M | In distribution | |
| 01.25.254S | In distribution | |
| 01.25.252S | In distribution | |
| 01.25.256L | In distribution | |
| 01.25.251L | In distribution | |
| 01.25.253S | In distribution | |
| 01.25.245S | In distribution | |
| 01.25.256S | In distribution | |
| 01.25.246S | In distribution | |
| 01.25.244M | In distribution | |
| 01.25.246L | In distribution | |
| 01.25.251S | In distribution | |
| 01.25.240L | In distribution | |
| 01.25.246M | In distribution | |
| 01.25.248L | In distribution | |
| 01.25.244S | In distribution | |
| 01.25.255S | In distribution | |
| 01.25.242M | In distribution | |
| 01.25.249S | In distribution | |
| 01.25.247L | In distribution | |
| 01.25.241S | In distribution | |
| 01.25.254M | In distribution | |
| 01.25.243S | In distribution | |
| 01.25.255M | In distribution | |
| 01.25.243M | In distribution | |
| 01.25.243L | In distribution | |
| 01.25.240M | In distribution | |
| 01.25.249M | In distribution | |
| 01.25.249L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Masterloc Femoral Stems | Medacta International SA | 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.