Mectron

MP0745 is an osteoplasty surgical insert to be used in conjunction with Mectron Piezosurgery handpieces

Registry build 21.09.26
6manufacturers in China registered for this device type
11catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Beijing (2), Shanghai (1).

Chinese manufacturers registered for FDA product code JDX
Manufacturer City Province Registered as Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 17
Shenzhen Perfect Idea Technology Limited Shenzhen Guangdong Contract manufacturer 10
Smtp Medical Co., Ltd. Daxing District Beijing Manufacturer 2
Huaan Hengyi (Beijing) Medical Technology Co., Ltd. Beijing Beijing Contract manufacturer 2
Shenzhen Codyson Electrical Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for Mectron
Listed by Mectron SPA
FDA product code JDX
Device type Instrument, Surgical, Sonic And Accessory/Attachment
Device class Class 2
Regulation 21 CFR 888.4580
510(k) K122322
Record published 2022-11-09
Record revised 2023-06-06 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Mectron
Catalogue number Size Status
EXL1 In distribution
EXL2 In distribution
EXL3 In distribution
MANIPOLO PIEZOSURGERY MEDICAL+ In distribution
OT1504 In distribution
MT1204 In distribution
MF0804+ In distribution
MF0702 + In distribution
MT1412 + In distribution
OP1045 -US In distribution
MP0745 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Acteon Satelec 95
Tors Radley Scientific Ltd 76
Smtp Smtp Medical Co., Ltd. 48
Oscar PRO Orthofix SRL 36
Ultra-Drive® Tool Biomet Orthopedics 11
Oscar Orthosonics, Ltd. 2
Satelec Satelec 1
Ultra-Drive® Biomet Orthopedics 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer