PAO Cortical Screw

PAO Cortical Screw Ø3.5 L140

Registry build 21.09.26
31manufacturers in China registered for this device type
44catalogue 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 PAO Cortical Screw
Listed by Medacta International SA, Switzerland
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
510(k) K211435
Record published 2021-08-17
Record revised 2024-02-19 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for PAO Cortical Screw
Catalogue number Size Status
05.07.0025 In distribution
05.07.0017 In distribution
05.07.0019 In distribution
05.07.0037 In distribution
05.07.0008 In distribution
05.07.0001 In distribution
05.07.0005 In distribution
05.07.0038 In distribution
05.07.0010 In distribution
05.07.0022 In distribution
05.07.0002 In distribution
05.07.0018 In distribution
05.07.0034 In distribution
05.07.0020 In distribution
05.07.0036 In distribution
05.07.0004 In distribution
05.07.0006 In distribution
05.07.0030 In distribution
05.07.0013 In distribution
05.07.0007 In distribution
05.07.0033 In distribution
05.07.0039 In distribution
05.07.0009 In distribution
05.07.0026 In distribution
05.07.0015 In distribution
05.07.0042 In distribution
05.07.0016 In distribution
05.07.0041 In distribution
05.07.0044 In distribution
05.07.0027 In distribution
05.07.0029 In distribution
05.07.0043 In distribution
05.07.0040 In distribution
05.07.0021 In distribution
05.07.0003 In distribution
05.07.0024 In distribution
05.07.0011 In distribution
05.07.0028 In distribution
05.07.0014 In distribution
05.07.0031 In distribution
05.07.0012 In distribution
05.07.0035 In distribution
05.07.0032 In distribution
05.07.0023 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