Restoration
Acetabular Shell w/ Scr Hls
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (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 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | JDJ |
| Device type | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K970957 |
| Record published | 2015-09-24 |
| Record revised | 2020-09-09 (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 |
| Sizes | Outer diameter 52 to 72 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2083-0064 | Outer Diameter 64.0 mm | In distribution |
| 2083-0060 | Outer Diameter 60.0 mm | In distribution |
| 2083-0072 | Outer Diameter 72.0 mm | In distribution |
| 2083-0052 | Outer Diameter 52.0 mm | In distribution |
| 2083-0068 | Outer Diameter 68.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mesh, Surgical, Acetabular, Hip, Prosthesis | Depuy Orthopaedics, Inc. | 35 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | Zimmer, Inc. | 30 |
| Contour | Smith & Nephew, Inc. | 19 |
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.