Echelon
Echelon Primary Stand Offset Trial Neck Size 13-14
5manufacturers in China registered for this device type
122catalogue 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 11) |
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 |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71350185 | In distribution | |
| 71351215 | In distribution | |
| 71353240 | In distribution | |
| 71350150 | In distribution | |
| 71368412 | In distribution | |
| 71350170 | In distribution | |
| 71351100 | In distribution | |
| 71351900 | In distribution | |
| 71351110 | In distribution | |
| 71367223 | In distribution | |
| 71351205 | In distribution | |
| 71367202 | In distribution | |
| 71351190 | In distribution | |
| 71350120 | In distribution | |
| 71368016 | In distribution | |
| 71368814 | In distribution | |
| 71350110 | In distribution | |
| 71367103 | In distribution | |
| 71367101 | In distribution | |
| 71368017 | In distribution | |
| 71350155 | In distribution | |
| 71368415 | In distribution | |
| 71367014 | In distribution | |
| 71368014 | In distribution | |
| 71368416 | In distribution | |
| 71368616 | In distribution | |
| 71351220 | In distribution | |
| 71351165 | In distribution | |
| 71353235 | In distribution | |
| 71367017 | In distribution | |
| 71351145 | In distribution | |
| E0016889-1 | In distribution | |
| 71350130 | In distribution | |
| 71367201 | In distribution | |
| 71368418 | In distribution | |
| 71351115 | In distribution | |
| 71367203 | In distribution | |
| 71368514 | In distribution | |
| 71350165 | In distribution | |
| 71364100 | In distribution | |
| 71367204 | In distribution | |
| 71350140 | In distribution | |
| 71351210 | In distribution | |
| 71350105 | In distribution | |
| 71350145 | In distribution | |
| 71367224 | In distribution | |
| 71350125 | In distribution | |
| 71350115 | In distribution | |
| 71368011 | In distribution | |
| 71368414 | In distribution | |
| 71350175 | In distribution | |
| 71350095 | In distribution | |
| 71351195 | In distribution | |
| 71368315 | In distribution | |
| 71368015 | In distribution | |
| 71368012 | In distribution | |
| 71367010 | In distribution | |
| 71368018 | In distribution | |
| 71351185 | In distribution | |
| 71368714 | In distribution | |
| 71350160 | In distribution | |
| 71351125 | In distribution | |
| 71350135 | In distribution | |
| 71351155 | In distribution | |
| 71364014 | In distribution | |
| 71353225 | In distribution | |
| 71368712 | In distribution | |
| 71350180 | In distribution | |
| 71367016 | In distribution | |
| 71351150 | In distribution | |
| 71367011 | In distribution | |
| 71368614 | In distribution | |
| 71368013 | In distribution | |
| 71351120 | In distribution | |
| 71367015 | In distribution | |
| 71367018 | In distribution | |
| 71368612 | In distribution | |
| 71351140 | In distribution | |
| 71353230 | In distribution | |
| 71351160 | In distribution | |
| 71350090 | In distribution | |
| 71367012 | In distribution | |
| 71368413 | In distribution | |
| 71368516 | In distribution | |
| 71351130 | In distribution | |
| 71351175 | In distribution | |
| 71367034 | In distribution | |
| 71368318 | In distribution | |
| 71368314 | In distribution | |
| 71350100 | In distribution | |
| 71368317 | In distribution | |
| 71368512 | In distribution | |
| E0016768-1 | In distribution | |
| 71368313 | In distribution | |
| 71364101 | In distribution | |
| 71368812 | In distribution | |
| 71368312 | In distribution | |
| 71351180 | In distribution | |
| 71368316 | In distribution | |
| 71351170 | In distribution | |
| 71367102 | In distribution | |
| 71367013 | In distribution | |
| 71351135 | In distribution | |
| 71367221 | In distribution | |
| 71367222 | In distribution | |
| 71351200 | In distribution | |
| 71368417 | In distribution | |
| 71368319 | Withdrawn | |
| 71350200 | Withdrawn | |
| 71368320 | Withdrawn | |
| 71350195 | Withdrawn | |
| 71367019 | Withdrawn | |
| 71368019 | Withdrawn | |
| 71368020 | Withdrawn | |
| 71367020 | Withdrawn | |
| 71368322 | Withdrawn | |
| 71368321 | Withdrawn | |
| 71368421 | Withdrawn | |
| 71368420 | Withdrawn | |
| 71368419 | Withdrawn | |
| 71368422 | Withdrawn | |
| 71350190 | Withdrawn |
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 |
| 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 |
| SMF | Smith & Nephew, Inc. | 41 |
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.