TiMesh®

Screw 9011640 Timesh 1.6X4.0MM SDS OPT 1

Registry build 21.09.26
31manufacturers in China registered for this device type
60catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWC
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11

Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone

Record

Regulatory record for TiMesh®
Listed by Medtronic PS Medical, United States
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
510(k) K062348
Record published 2015-07-15
Record revised 2022-09-16 (version 9)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Packaging Pack of 5
Sizes Length 3 to 46 mm; width 1.3 to 2.2 mm; outer diameter 1.6 to 18 mm; lumen/inner diameter 3 mm

Catalogue Numbers

Catalogue numbers for TiMesh®
Catalogue number Size Per pack Status
518-203 Width 1.8 mm 6 In distribution
018030 Length 3.0 mm 6 In distribution
8001201 In distribution
8004100 In distribution
8009000 In distribution
8001201 In distribution
8001503 In distribution
015-270 Outer Diameter 8.4 mm In distribution
015-1306 Length 6.0 mm In distribution
805 Width 2.2 mm 6 In distribution
8001222 In distribution
8004200 In distribution
515-203 Width 1.5 mm 6 In distribution
015051 Length 5.0 mm In distribution
8001215 In distribution
8001222 In distribution
8001503 In distribution
8009002 In distribution
8001505 In distribution
015-262-11 Outer Diameter 11.0 mm In distribution
8001830 Length 3.0 mm 6 In distribution
8001850 Width 1.8 mm 6 In distribution
515-204 Width 1.5 mm 6 In distribution
015-270 In distribution
518-205 Length 5.0 mm 6 In distribution
8001205 In distribution
9011640 Length 4.0 mm In distribution
015031 Length 3.0 mm In distribution
8004105 In distribution
015030 Length 3.0 mm 6 In distribution
8001605 In distribution
9001640 Width 1.6 mm 6 In distribution
9001635 Length 3.5 mm 6 In distribution
015-262-18 Outer Diameter 18.0 mm In distribution
8001215 In distribution
805 Length 5.0 mm In distribution
015050 Width 1.5 mm 6 In distribution
9011635 Length 3.5 mm In distribution
015-262-14 Outer Diameter 14.0 mm In distribution
433 In distribution
015041 Length 4.0 mm In distribution
433 In distribution
8009008 In distribution
8001505 In distribution
8009008 In distribution
8001605 In distribution
8009002 In distribution
015-262-18 In distribution
8011850 Length 5.0 mm In distribution
015-262-14 In distribution
018051 Width 1.8 mm In distribution
8011830 Width 1.8 mm In distribution
018050 Width 1.8 mm 6 In distribution
8009000 In distribution
8001205 Outer Diameter 1.6 mm In distribution
804 Width 2.2 mm 6 In distribution
803 Length 3.0 mm 6 In distribution
018031 Length 3.0 mm In distribution
015-262-11 In distribution
015040 Width 1.5 mm 6 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Screw, Fixation, Bone Synthes Gmbh 3,975
Aptus Medartis Inc. 3,623
Acumed Acumed LLC 3,187
Arthrex® Arthrex, Inc. 2,781
OsteoMed Osteomed 2,764
Screw, Fixation, Bone AAP Implantate AG 2,176
Screw, Fixation, Bone Zimmer, Inc. 1,993
Arix System Bone Screw Jeil Medical Corporation 1,875
Cannulated Screw System + Tyber Medical 1,814
Cannulated Compression Headless Screw Tyber Medical 1,621
Microware Bone Plates and Bone Screws Microware Precision Co., Ltd. 1,601
Anthem Globus Medical, Inc. 1,538

Showing 12 of 5,775. All products under Screw, 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.

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