Synergy

Synergy CEM Collared Trial Neck Standard Offset Size 10-11

Registry build 21.09.26
5manufacturers in China registered for this device type
102catalogue 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 Synergy
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 2021-07-28
Record revised 2023-09-07 (version 8)

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 2018-06-03

Catalogue Numbers

Catalogue numbers for Synergy
Catalogue number Size Status
E0017430-4 In distribution
E0015832-4 In distribution
E0016079-5 In distribution
E0016079-3 In distribution
E0016302-10 In distribution
71366711 In distribution
E0017430-6 In distribution
E0016205-6 In distribution
71366408 In distribution
71366910 In distribution
71366714 In distribution
71932356 In distribution
E0016205-1 In distribution
E0017430-8 In distribution
E0016079-2 In distribution
E0017141-3 In distribution
E0016079-1 In distribution
E0015832-9 In distribution
71366912 In distribution
71932359 In distribution
E0016079-8 In distribution
E0016079-10 In distribution
E0017430-2 In distribution
E0016302-2 In distribution
E0017141-5 In distribution
71366414 In distribution
E0016205-2 In distribution
E0016302-8 In distribution
E0016589-2 In distribution
E0017141-4 In distribution
71366215 In distribution
E0016745-1 In distribution
E0016205-7 In distribution
71932350 In distribution
E0017430-3 In distribution
71932351 In distribution
E0016589-1 In distribution
71366209 In distribution
E0016205-11 In distribution
E0017430-7 In distribution
E0016589-3 In distribution
E0015832-8 In distribution
71366908 In distribution
71366514 In distribution
71366508 In distribution
E0016079-9 In distribution
E0016302-6 In distribution
E0016205-3 In distribution
E0016302-4 In distribution
71366716 In distribution
71366916 In distribution
71932352 In distribution
71366718 In distribution
E0017141-2 In distribution
71932360 In distribution
71932358 In distribution
E0016589-5 In distribution
71932361 In distribution
E0016205-10 In distribution
71932362 In distribution
71366211 In distribution
E0017430-5 In distribution
71366708 In distribution
E0015832-1 In distribution
71932349 In distribution
E0016205-9 In distribution
71366717 In distribution
71932353 In distribution
E0016302-3 In distribution
71366712 In distribution
E0016205-5 In distribution
71366710 In distribution
E0016079-4 In distribution
E0015832-10 In distribution
E0016302-9 In distribution
E0016302-7 In distribution
E0016205-8 In distribution
E0017430-10 In distribution
71932355 In distribution
71932357 In distribution
E0015832-5 In distribution
E0015832-2 In distribution
E0015832-3 In distribution
E0016079-6 In distribution
E0015832-7 In distribution
71366914 In distribution
71366715 In distribution
71366213 In distribution
E0016205-4 In distribution
E0016302-5 In distribution
71932363 In distribution
E0016534-1 In distribution
71366709 In distribution
71366217 In distribution
71932354 In distribution
E0016589-4 In distribution
71366713 In distribution
E0015832-6 In distribution
E0016302-1 In distribution
E0016079-7 In distribution
E0017430-1 In distribution
71928471 Withdrawn

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
Polar Smith & Nephew, Inc. 132
Anthology Smith & Nephew, Inc. 129
Echelon Smith & Nephew, Inc. 122
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