B-P Total HIP System
B-P HIP Femoral Head W/Ultracoat - 28 MM + 10 MM
5manufacturers in China registered for this device type
20catalogue numbers in this listing
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 | Endotec, Inc., United States |
|---|---|
| FDA product code | LZY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| 510(k) | K892059 |
| Record published | 2015-09-17 |
| Record revised | 2024-04-11 (version 7) |
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 |
| Storage | Storage environment temperature 5 to 40 °C; Handling environment temperature 5 to 40 °C |
| Sizes | Outer diameter 28 to 32 mm; length 1 to 20 mm |
| Distribution end date | 2024-03-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-34-0128 | Length 1 mm | In distribution |
| 01-14-1528 | Length 15 mm | In distribution |
| 01-34-0528 | Length 5 mm | In distribution |
| 01-34-0032 | Outer Diameter 32 mm | In distribution |
| 01-34-1028 | Length 10 mm | In distribution |
| 01-34-0532 | Length 5 mm | In distribution |
| 01-34-1032 | Length 10 mm | In distribution |
| 01-34-2032 | Length 20 mm | In distribution |
| 01-14-1028 | Length 10 mm | Withdrawn |
| 01-34-2028 | Length 20 mm | Withdrawn |
| 01-14-0032 | Outer Diameter 32 mm | Withdrawn |
| 01-34-1532 | Length 15 mm | Withdrawn |
| 01-14-1532 | Length 15 mm | Withdrawn |
| 01-34-1528 | Length 15 mm | Withdrawn |
| 01-14-0532 | Length 5 mm | Withdrawn |
| 01-14-2028 | Length 20 mm | Withdrawn |
| 01-14-0128 | Length 1 mm | Withdrawn |
| 01-14-0528 | Length 5 mm | Withdrawn |
| 01-14-2032 | Length 20 mm | Withdrawn |
| 01-14-1032 | Length 10 mm | Withdrawn |
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 |
| 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
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.