Montblanc Cortical Screw

37 catalogue numbers from 35C-016, listed by Medifield Medical Co., Ltd., South Korea, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.

Registry build 21.09.26
31manufacturers in China registered for this device type
37catalogue 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 Montblanc Cortical Screw
Listed by Medifield Medical Co., Ltd., South Korea
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Manufacturer
510(k) K243368
Record published 2026-06-22

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Packaging Cartoon of 10, pack of 10

Catalogue Numbers

Catalogue numbers for Montblanc Cortical Screw
Catalogue number Size Status
35C-016 In distribution
25C-018 In distribution
25C-022 In distribution
35C-052 In distribution
35C-040 In distribution
35C-024 In distribution
35C-056 In distribution
35C-050 In distribution
25C-016 In distribution
25C-024 In distribution
35C-012 In distribution
35C-018 In distribution
25C-010 In distribution
35C-036 In distribution
35C-022 In distribution
35C-020 In distribution
25C-020 In distribution
25C-014 In distribution
25C-012 In distribution
35C-046 In distribution
35C-032 In distribution
35C-026 In distribution
35C-058 In distribution
25C-008 In distribution
35C-028 In distribution
35C-044 In distribution
35C-008 In distribution
35C-055 In distribution
35C-030 In distribution
35C-034 In distribution
35C-054 In distribution
35C-010 In distribution
35C-014 In distribution
35C-060 In distribution
35C-048 In distribution
35C-038 In distribution
35C-042 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