Optimom Modular Heads
OPTIMOM HEAD (12/14) SIZE 10/56mm -4 OFFSET
10manufacturers in China registered for this device type
49catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Corin Limited, United Kingdom |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111911 |
| Record published | 2016-08-17 |
| Record revised | 2019-02-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation 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 |
|---|---|---|
| E479.854 | In distribution | |
| E279.508 | In distribution | |
| E279.679 | In distribution | |
| E279.529 | In distribution | |
| E079.744 | In distribution | |
| E079.652 | In distribution | |
| E079.756 | In distribution | |
| E079.752 | In distribution | |
| E279.523 | In distribution | |
| E479.746 | In distribution | |
| E279.517 | In distribution | |
| E479.850 | In distribution | |
| 279.050 | In distribution | |
| E279.526 | In distribution | |
| E079.852 | In distribution | |
| E079.640 | In distribution | |
| E079.748 | In distribution | |
| E279.527 | In distribution | |
| E279.513 | In distribution | |
| E279.676 | In distribution | |
| E079.648 | In distribution | |
| E479.754 | In distribution | |
| E279.507 | In distribution | |
| E279.514 | In distribution | |
| E479.646 | In distribution | |
| E079.644 | In distribution | |
| E479.742 | In distribution | |
| E279.510 | In distribution | |
| E079.656 | In distribution | |
| E079.840 | In distribution | |
| E479.642 | In distribution | |
| E479.750 | In distribution | |
| E279.677 | In distribution | |
| E279.678 | In distribution | |
| E279.530 | In distribution | |
| E079.844 | In distribution | |
| E479.842 | In distribution | |
| E479.654 | In distribution | |
| E079.848 | In distribution | |
| E479.846 | In distribution | |
| E279.680 | In distribution | |
| E479.650 | In distribution | |
| E279.675 | In distribution | |
| E079.740 | In distribution | |
| E279.674 | In distribution | |
| E079.856 | In distribution | |
| E279.524 | In distribution | |
| E279.511 | In distribution | |
| E279.516 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 95 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 95 |
| Instrument | Howmedica Osteonics Corp | 94 |
| UHR | Howmedica Osteonics Corp | 75 |
| Austin Moore | Howmedica Osteonics Corp | 67 |
| B-P Total HIP System | Endotec, Inc. | 66 |
| CS2 Acetabular Cup System | Consensus Orthopedics, Inc. | 64 |
| DJO Surgical | Encore Medical, L.P. | 62 |
| Restoration | Howmedica Osteonics Corp | 56 |
| Corin Unipolar Modular Head | Corin Limited | 36 |
| Perfecta | Microport Orthopedics Inc. | 35 |
Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal
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.