Trigen
15.5MM Sculptor Pilot Nose Interchange Reamer Head
5manufacturers in China registered for this device type
66catalogue 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 | 2015-09-28 |
| Record revised | 2024-09-11 (version 10) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71118213 | In distribution | |
| 71631130 | In distribution | |
| 71654509 | In distribution | |
| 71118245 | In distribution | |
| 71631039 | In distribution | |
| 71118237 | In distribution | |
| 71118223 | In distribution | |
| 71631120 | In distribution | |
| 71118249 | In distribution | |
| 71631116 | In distribution | |
| 71674062 | In distribution | |
| 71118251 | In distribution | |
| 71118260 | In distribution | |
| 71654511 | In distribution | |
| 71118242 | In distribution | |
| 71631114 | In distribution | |
| 71118220 | In distribution | |
| 71654515 | In distribution | |
| 71631150 | In distribution | |
| 71118240 | In distribution | |
| E0018221-2 | In distribution | |
| 71631187 | In distribution | |
| 71118235 | In distribution | |
| 71118222 | In distribution | |
| 71118221 | In distribution | |
| 71118254 | In distribution | |
| 71118228 | In distribution | |
| 71118233 | In distribution | |
| 71118227 | In distribution | |
| 71631184 | In distribution | |
| 71118225 | In distribution | |
| 71674092 | In distribution | |
| 71118229 | In distribution | |
| 71674063 | In distribution | |
| 71631192 | In distribution | |
| 71118256 | In distribution | |
| 71118231 | In distribution | |
| 71631118 | In distribution | |
| 71654514 | In distribution | |
| 71654508 | In distribution | |
| 71654513 | In distribution | |
| E0017260-1 | In distribution | |
| 71118238 | In distribution | |
| 71118253 | In distribution | |
| E0017292-1 | In distribution | |
| 71118236 | In distribution | |
| 71118248 | In distribution | |
| 71118246 | In distribution | |
| 71118243 | In distribution | |
| 71118239 | In distribution | |
| 71118232 | In distribution | |
| 71118241 | In distribution | |
| 71118226 | In distribution | |
| 71118250 | In distribution | |
| 71118230 | In distribution | |
| 71118234 | In distribution | |
| 71118252 | In distribution | |
| E0018221-1 | In distribution | |
| 71118244 | In distribution | |
| E0016878-1 | In distribution | |
| E0016835-1 | In distribution | |
| 71118247 | In distribution | |
| 71118255 | In distribution | |
| 71674082 | In distribution | |
| 71118224 | In distribution | |
| 71674076 | 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 |
| 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.