Restoris
12 catalogue numbers from 186028-02, listed by Mako Surgical Corp., United States, under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
12catalogue 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 |
|---|---|---|---|---|
| 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 | Mako Surgical Corp., United States |
|---|---|
| FDA product code | OQH |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K112802 |
| Record published | 2015-09-24 |
| Record revised | 2020-04-06 (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 |
| Sizes | Length 35 to 45 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 186028-02 | Neck Length: 3.5 Millimeter | In distribution |
| 186003-11 | Size: 11 | In distribution |
| 186004-09 | Size: 9 | In distribution |
| 186628-02 | Size: LGE | In distribution |
| 186040-03 | Diameter: 40.0 Millimeter | In distribution |
| 186005-45 | Length 45.0 mm | In distribution |
| 186004-12 | Size: 12 | In distribution |
| 186004-05 | Size: 5 | In distribution |
| 186004-04 | Size: 4 | In distribution |
| 186003-03 | Size: 3 | In distribution |
| 186003-07 | Size: 7 | In distribution |
| 186005-35 | Length 35.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G7® | Biomet Orthopedics | 61 |
| G7 Acetabular Liner | Biomet Orthopedics | 41 |
| G7® Longevity® | Zimmer, Inc. | 20 |
| Restoris Xlve | Mako Surgical Corp. | 20 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 17 |
| Arcos® One-piece Revision System | Biomet Orthopedics | 16 |
| G7® Vivacit-E® | Zimmer, Inc. | 15 |
| RingLoc Hip System | Biomet Orthopedics | 15 |
| Continuum® Trilogy® Allofit® Vivacit-E® | Zimmer, Inc. | 14 |
| G7® Acetabular System | Biomet Orthopedics | 11 |
| Sirius | Biomet Orthopedics | 7 |
| G7 Osseoti Acetabular Shell | Biomet Orthopedics | 6 |
Showing 12 of 42. All products under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
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.