DRPx Locking Distal Radius Plate System
Distal Radius Plate, Standard, 4H Right
22manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Orthopaedic Implant Company, THE |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K202971 |
| Record published | 2022-05-06 |
| Record revised | 2023-04-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 45 to 210 mm; outer diameter 2 to 2.8 mm; lumen/inner diameter 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSP-08210 | Length 210 mm | In distribution |
| DR28-095C | Length 95 mm | In distribution |
| DRPX-S0459R | Length 59 mm | In distribution |
| DRPX-N0345R | Length 45 mm | In distribution |
| DG-2020 | In distribution | |
| 01-SF25 | In distribution | |
| DRPX-N0453R | Length 53 mm | In distribution |
| DRPX-S0789R | Length 89 mm | In distribution |
| 01-SF26 | In distribution | |
| DRPX-S0789L | Length 89 mm | In distribution |
| 01-SF24 | Lumen/Inner Diameter 1.6 mm | In distribution |
| 01-DRPX01R | In distribution | |
| 01-DRPX02L | In distribution | |
| DRPX-N0345L | Length 45 mm | In distribution |
| DR20-095C | Length 95 mm | In distribution |
| 01-DRPX-00 | In distribution | |
| DRPX-N0453L | Length 53 mm | In distribution |
| OIC-NK1 | In distribution | |
| DSP-08160 | Length 160 mm | In distribution |
| LG-0020 | In distribution | |
| SG-0020 | In distribution | |
| DRPX-S0351R | Length 51 mm | In distribution |
| 01-DRPX02R | In distribution | |
| OIC-NK2 | In distribution | |
| 01-T06090 | Length 90 mm | In distribution |
| DRPX-S0459L | Length 59 mm | In distribution |
| 01-DRPX01L | In distribution | |
| DRPX-S0351L | Length 51 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
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.