DJO Surgical
Stem, HIP, FH, 450 Series, SIZE8MM
5manufacturers in China registered for this device type
22catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Zhejiang (1). 3 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | JDG |
| Device type | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K961890 |
| Record published | 2017-08-07 |
| Record revised | 2020-12-15 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 460-01-135 | In distribution | |
| 460-01-080 | In distribution | |
| 400-03-004 | In distribution | |
| 450-01-135 | In distribution | |
| 450-01-165 | In distribution | |
| 460-01-165 | In distribution | |
| 460-01-105 | In distribution | |
| 400-03-008 | In distribution | |
| 460-01-120 | In distribution | |
| 400-03-003 | In distribution | |
| 450-01-120 | In distribution | |
| 400-03-005 | In distribution | |
| 450-01-090 | In distribution | |
| 450-01-105 | In distribution | |
| 450-01-150 | In distribution | |
| 460-01-150 | In distribution | |
| 450-01-080 | In distribution | |
| 400-03-001 | In distribution | |
| 400-03-006 | In distribution | |
| 400-03-002 | In distribution | |
| 460-01-090 | In distribution | |
| 400-03-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 554 |
| Emperion | Smith & Nephew, Inc. | 262 |
| Reflection | Smith & Nephew, Inc. | 253 |
| Spii Model Lubinus | Waldemar Link GmbH & Co. KG | 174 |
| Polar | Smith & Nephew, Inc. | 132 |
| Anthology | Smith & Nephew, Inc. | 129 |
| Echelon | Smith & Nephew, Inc. | 122 |
| Synergy | Smith & Nephew, Inc. | 102 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | Smith & Nephew, Inc. | 93 |
| Trigen | Smith & Nephew, Inc. | 66 |
| Prosthesis Head B | Waldemar Link GmbH & Co. KG | 62 |
| Corin Taper-Fit Total Hip System | Corin Limited | 55 |
Showing 12 of 71. All products under Prosthesis, Hip, Femoral Component, Cemented, Metal
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2011-08-17 | Not classified | Packaging | The sterility has the potential to be compromised. | 169 units | 2012-05-11 |
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.