Libertas
Modular E-XLPE Liner Size MH/32 Elevated Wall
5manufacturers in China registered for this device type
13catalogue 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 |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| 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 |
Record
| Listed by | Maxx Orthopedics Inc., United States |
|---|---|
| FDA product code | OQI |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K192989 |
| Record published | 2022-12-08 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MO-MLHH-MH/28 | In distribution | |
| MO-MLHH-MH/32 | In distribution | |
| MO-MLLH-MH/32 | In distribution | |
| MO-MLHH-MF/28 | In distribution | |
| MO-MLLH-MJ/40 | In distribution | |
| MO-MLHH-MF/36 | In distribution | |
| MO-MLHH-MJ/32 | In distribution | |
| MO-MLHH-MH/36 | In distribution | |
| MO-MLHH-MJ/36 | In distribution | |
| MO-MLLH-MK/36 | In distribution | |
| MO-MLHH-MK/32 | In distribution | |
| MO-MLLH-MK/40 | In distribution | |
| MO-MLHH-MK/36 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 260 |
| Epore® XO | implantcast GmbH | 64 |
| G7® | Biomet Orthopedics | 50 |
| InSitu Hip System | Nextstep Arthropedix | 50 |
| G7 Acetabular Liner | Biomet Orthopedics | 47 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | implantcast GmbH | 40 |
| Novation | Exactech, Inc. | 37 |
| Trinity Acetabular Hip System with ECiMa Liners | Corin Limited | 28 |
| Procotyl® Prime | Microport Orthopedics Inc. | 25 |
| AcuMatch | Exactech, Inc. | 23 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 23 |
| G7® Longevity® | Zimmer, Inc. | 23 |
Showing 12 of 164. All products under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192989 | 2020-10-29 |
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.