Polar

Polar Knock Plate With Threaded Hole

Registry build 21.09.26
5manufacturers in China registered for this device type
132catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDG
Manufacturer City Province Registered as Device types
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54

Record

Regulatory record for Polar
Listed by Smith & Nephew, Inc., United States
FDA product code JDG
Device type Prosthesis, Hip, Femoral Component, Cemented, Metal
Device class Class 2
Regulation 21 CFR 888.3360
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K123598
Record published 2020-07-24
Record revised 2024-09-11 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Polar
Catalogue number Size Status
E0017064-2 In distribution
E0017936-1 In distribution
E0016818-1 In distribution
E0016665-1 In distribution
E0018137-1 In distribution
E0017247-1 In distribution
E0018186-1 In distribution
E0017691-1 In distribution
E0016827-1 In distribution
E0017808-1 In distribution
E0018186-2 In distribution
E0016160-2 In distribution
E0016089-1 In distribution
E0017601-1 In distribution
E0017935-1 In distribution
E0016082-1 In distribution
E0016511-1 In distribution
E0016503-1 In distribution
E0017691-2 In distribution
E0017120-2 In distribution
E0015871-2 In distribution
E0015871-1 In distribution
E0017876-1 In distribution
E0017932-1 In distribution
E0017564-1 In distribution
E0016785-2 In distribution
E0018234-2 In distribution
E0017198-2 In distribution
E0017740-1 In distribution
E0016108-1 In distribution
E0017389-1 In distribution
E0015755-2 In distribution
E0018261-1 In distribution
E0015918-3 In distribution
E0016160-1 In distribution
E0017048-2 In distribution
E0018070-1 In distribution
E0015964-1 In distribution
E0016228-1 In distribution
E0017389-2 In distribution
E0016248-1 In distribution
E0016916-1 In distribution
E0016529-2 In distribution
E0017126-1 In distribution
E0017834-1 In distribution
E0017064-1 In distribution
E0018277-1 In distribution
E0016155-1 In distribution
E0015918-1 In distribution
E0016796-1 In distribution
E0016155-2 In distribution
E0017489-1 In distribution
E0018141-1 In distribution
E0016160-3 In distribution
E0016016-1 In distribution
E0016506-1 In distribution
E0016470-1 In distribution
E0018161-1 In distribution
E0017833-1 In distribution
E0016113-1 In distribution
E0017601-2 In distribution
E0015870-2 In distribution
E0016113-2 In distribution
E0016040-1 In distribution
E0018163-2 In distribution
E0016501-1 In distribution
E0016772-1 In distribution
E0016677-1 In distribution
E0017120-1 In distribution
E0017248-2 In distribution
E0016916-2 In distribution
E0016827-2 In distribution
E0017519-1 In distribution
E0016274-1 In distribution
E0016331-1 In distribution
E0016506-2 In distribution
E0016713-2 In distribution
E0015870-3 In distribution
E0017743-1 In distribution
E0016915-1 In distribution
E0016583-1 In distribution
E0016502-1 In distribution
E0016607-1 In distribution
E0016817-1 In distribution
E0017835-1 In distribution
E0017170-2 In distribution
E0018022-1 In distribution
E0017653-2 In distribution
E0016993-1 In distribution
E0018137-2 In distribution
E0016108-2 In distribution
E0018163-1 In distribution
E0016610-1 In distribution
E0016749-2 In distribution
E0016607-2 In distribution
E0018037-1 In distribution
E0018210-1 In distribution
E0017854-2 In distribution
E0018155-1 In distribution
E0017048-1 In distribution
E0017198-1 In distribution
E0017667-1 In distribution
E0016238-1 In distribution
E0017653-1 In distribution
E0016432-2 In distribution
E0017934-1 In distribution
E0016772-2 In distribution
E0016665-2 In distribution
E0017247-2 In distribution
E0017196-1 In distribution
E0015918-2 In distribution
E0017467-1 In distribution
E0018234-1 In distribution
E0016432-1 In distribution
E0017248-1 In distribution
E0016529-1 In distribution
E0017564-2 In distribution
E0016824-1 In distribution
E0017743-2 In distribution
E0016749-1 In distribution
E0016248-2 In distribution
E0017854-1 In distribution
E0016915-2 In distribution
E0018270-1 In distribution
E0017170-1 In distribution
E0016785-1 In distribution
E0017808-2 In distribution
E0016817-2 In distribution
E0016818-2 In distribution
E0016899-1 In distribution
E0016713-1 In distribution
E0017944-1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
R3 Smith & Nephew, Inc. 554
Emperion Smith & Nephew, Inc. 262
Reflection Smith & Nephew, Inc. 253
Spii Model Lubinus Waldemar Link GmbH & Co. KG 174
Anthology Smith & Nephew, Inc. 129
Echelon Smith & Nephew, Inc. 122
Synergy Smith & Nephew, Inc. 102
Prosthesis, Hip, Femoral Component, Cemented, Metal Smith & Nephew, Inc. 93
Trigen Smith & Nephew, Inc. 66
Prosthesis Head B Waldemar Link GmbH & Co. KG 62
Corin Taper-Fit Total Hip System Corin Limited 55
SMF Smith & Nephew, Inc. 41

Showing 12 of 71. All products under Prosthesis, Hip, Femoral Component, Cemented, Metal

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