Restoris Xlve
18 catalogue numbers from 186428-44, listed by Mako Surgical Corp., United States, under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| 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 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Mako Surgical Corp., United States |
|---|---|
| FDA product code | OQG |
| Device type | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K112802 |
| Record published | 2015-09-24 |
| 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 |
| Sizes | Height 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 186428-44 | Diameter: 44.0 Millimeter | In distribution |
| 186336-62 | Diameter: 62.0 Millimeter | In distribution |
| 186128-50 | Head Diameter: 28.0 Millimeter | In distribution |
| 186432-52 | Head Diameter: 32.0 Millimeter | In distribution |
| 186332-52 | Head Diameter: 32.0 Millimeter | In distribution |
| 186132-54 | Diameter: 54.0 Millimeter | In distribution |
| 186532-48 | Neck Length: 4.0 Millimeter | In distribution |
| 186336-66 | Diameter: 67.0 Millimeter | In distribution |
| 186136-54 | Head Diameter: 36.0 Millimeter | In distribution |
| 186236-58 | Head Diameter: 36.0 Millimeter | In distribution |
| 186232-54 | Head Diameter: 32.0 Millimeter | In distribution |
| 186228-50 | Diameter: 50.0 Millimeter | In distribution |
| 186336-54 | Diameter: 54.0 Millimeter | In distribution |
| 186532-50 | Diameter: 50.0 Millimeter | In distribution |
| 186436-58 | Height 4.0 mm | In distribution |
| 186428-50 | Head Diameter: 28.0 Millimeter | In distribution |
| 186232-52 | Head Diameter: 32.0 Millimeter | In distribution |
| 186236-54 | Diameter: 54.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| iTotal® Hip Replacement System | ConforMIS, Inc. | 131 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| DJO Surgical | Encore Medical, L.P. | 99 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 68 |
| G7 | Biomet Orthopedics | 54 |
| Vitelene® | Aesculap AG | 52 |
| Conformis Hip System | ConforMIS, Inc. | 51 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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.