Emperion

Emperion Sleeve Trial 11MM MED Cone Slotted Assy

Registry build 21.09.26
5manufacturers in China registered for this device type
262catalogue 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 Emperion
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 2015-08-30
Record revised 2024-09-11 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2022-03-17

Catalogue Numbers

Catalogue numbers for Emperion
Catalogue number Size Status
71364620 In distribution
71364580 In distribution
71364575 In distribution
71364560 In distribution
71364590 In distribution
71364555 In distribution
71364550 In distribution
71364545 In distribution
71364640 In distribution
71364500 In distribution
71364595 In distribution
71364565 In distribution
71364615 In distribution
71364525 In distribution
71364530 In distribution
71364570 In distribution
71364610 In distribution
71364635 In distribution
71364535 In distribution
71364600 In distribution
71364605 In distribution
71364585 In distribution
71364490 In distribution
71364630 In distribution
71364625 In distribution
71364515 In distribution
71364520 In distribution
71364540 In distribution
71364510 In distribution
71360929 Withdrawn
71361396 Withdrawn
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Showing 250 of 262 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
R3 Smith & Nephew, Inc. 554
Reflection Smith & Nephew, Inc. 253
Spii Model Lubinus Waldemar Link GmbH & Co. KG 174
Polar Smith & Nephew, Inc. 132
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