Mectron
The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including…
The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: – Otolaryngology – Oral/maxillofacial – Hand and foot – Neurosurgery – Spine – Plastic/reconstructive, and – Orthopedic surgery The device may also be used with endoscopic visual assistance to perform the above listed procedures.
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Record
| Listed by | Mectron SPA |
|---|---|
| FDA product code | HWE |
| Device type | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| 510(k) | K132848 |
| Record published | 2016-08-30 |
| Record revised | 2024-04-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 70 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal |
| Sizes | Outer diameter 0.8 to 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIEZOSURGERY FLEX | In distribution | |
| MT3-20 | In distribution | |
| PS MEDICAL TORQUE WRENCH | In distribution | |
| MP3-a30 | In distribution | |
| UNIVR | In distribution | |
| MT11L-10 | In distribution | |
| MD2-10 | Outer Diameter 1.0 mm | In distribution |
| MT4-20 + | In distribution | |
| MT9-13 | In distribution | |
| MT7-3 | In distribution | |
| MP1 | In distribution | |
| MT2L-4 | In distribution | |
| MT8-20 L | In distribution | |
| PIEZOSURGERY FLEX -US | In distribution | |
| PIEZOSURGERY PLUS | In distribution | |
| MF6 | Outer Diameter 5 mm | In distribution |
| PIEZOSURGERY PLUS – US | In distribution | |
| MT3-8 | In distribution | |
| MT1-10 | In distribution | |
| PS MEDICAL + HANDPIECE | In distribution | |
| PS MEDICAL L TORQUE WRENCH | In distribution | |
| MD3-12 | Outer Diameter 1.2 mm | In distribution |
| MD2-08 | Outer Diameter 0.8 mm | In distribution |
| MT1-20 | In distribution | |
| MF2 | Outer Diameter 2.4 mm | In distribution |
| MP5 L | In distribution | |
| MF3 | Outer Diameter 1.7 mm | In distribution |
| MT1S-1O | In distribution | |
| MP4 + | In distribution | |
| MT6S-10 | In distribution | |
| MT10-20+ | In distribution | |
| MT5-10 L | In distribution | |
| MD3-16 | Outer Diameter 1.6 mm | In distribution |
| MF1 | In distribution | |
| MF5 | In distribution | |
| MD3-18 | Outer Diameter 1.8 mm | In distribution |
| MF4 | In distribution | |
| PS MEDICAL HANDPIECE | In distribution | |
| MT2R-4 | In distribution | |
| MP2 | In distribution | |
| MD3-14 | Outer Diameter 1.4 mm | In distribution |
| MP6 L | In distribution | |
| PS MEDICAL + TORQUE WRENCH | In distribution | |
| MT11R-10 | In distribution | |
| MT4-10 + | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZX | Imedicom Co., Ltd. | 441 |
| Arthrex® | Arthrex, Inc. | 391 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Stryker GmbH | 284 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 231 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Synthes Gmbh | 226 |
| Brasseler EZX | Imedicom Co., Ltd. | 187 |
| Conserve® | Microport Orthopedics Inc. | 158 |
| R3 | Smith & Nephew, Inc. | 147 |
| Trigen | Smith & Nephew, Inc. | 139 |
| MicroPort | Microport Orthopedics Inc. | 134 |
| Made-To-Order | Tornier Inc. | 131 |
| Profemur® | Microport Orthopedics Inc. | 129 |
Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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.