Mesh, Surgical, Acetabular, Hip, Prosthesis
PROTRUSIO CAGE CEMENTED ACETABULAR RECONSTRUCTION 60mm OD 57mm ID RIGHT
2manufacturers in China registered for this device type
35catalogue 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 | Depuy Orthopaedics, Inc., 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, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K962007 |
| Record published | 2015-09-24 |
| Record revised | 2025-02-06 (version 7) |
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 |
| Distribution end date | 2021-10-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1011-40-070 | In distribution | |
| 1011-03-501 | In distribution | |
| 1011-40-020 | In distribution | |
| 1011-40-035 | In distribution | |
| 1011-07-501 | In distribution | |
| 1011-01-501 | In distribution | |
| 1011-06-501 | In distribution | |
| 1011-40-065 | In distribution | |
| 1011-40-055 | In distribution | |
| 1011-40-015 | In distribution | |
| 1011-40-045 | In distribution | |
| 1011-05-501 | In distribution | |
| 1011-40-030 | In distribution | |
| 1011-40-060 | In distribution | |
| 1011-40-050 | In distribution | |
| 1011-04-501 | In distribution | |
| 1011-02-501 | In distribution | |
| 1011-09-501 | In distribution | |
| 1011-40-025 | In distribution | |
| 1011-08-501 | In distribution | |
| 1011-40-040 | In distribution | |
| 1011-86-000 | Withdrawn | |
| 1011-75-000 | Withdrawn | |
| 1011-77-000 | Withdrawn | |
| 1011-83-000 | Withdrawn | |
| 1011-85-000 | Withdrawn | |
| 1011-78-000 | Withdrawn | |
| 1011-72-000 | Withdrawn | |
| 1011-74-000 | Withdrawn | |
| 1011-76-000 | Withdrawn | |
| 1011-84-000 | Withdrawn | |
| 1011-73-000 | Withdrawn | |
| 1011-71-000 | Withdrawn | |
| 1011-82-000 | Withdrawn | |
| 1011-81-000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mesh, Surgical, Acetabular, Hip, Prosthesis | Zimmer, Inc. | 30 |
| Contour | Smith & Nephew, Inc. | 19 |
| Restoration | Howmedica Osteonics Corp | 5 |
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.