Spectron
Spectron EF 12/14 Long Straight/Neck Replacement Broach 195MM Medium
5manufacturers in China registered for this device type
26catalogue 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 | Smith & Nephew, Inc., 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, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123598 |
| Record published | 2015-08-30 |
| Record revised | 2024-09-11 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71365004 | In distribution | |
| 71365081 | In distribution | |
| 71365128 | In distribution | |
| 71365095 | In distribution | |
| 71365111 | In distribution | |
| 71365133 | In distribution | |
| 119817 | In distribution | |
| 71365092 | In distribution | |
| 71365098 | In distribution | |
| 71365036 | In distribution | |
| 71365001 | In distribution | |
| 71365094 | In distribution | |
| 71365003 | In distribution | |
| 71365083 | In distribution | |
| 71365025 | In distribution | |
| 71365091 | In distribution | |
| 71365115 | In distribution | |
| 71365023 | In distribution | |
| 71365127 | In distribution | |
| 71365082 | In distribution | |
| 71365005 | In distribution | |
| 71365093 | In distribution | |
| 71365085 | In distribution | |
| 71365084 | In distribution | |
| 71365099 | In distribution | |
| 71365002 | 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
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.