Legion

Genesis II Symmetrical Posterior Condyles Anterior CUT First Ream Through Cruciate Retaining Femoral Trial Tray

Registry build 21.09.26
105manufacturers in China registered for this device type
73catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for Legion
Listed by Smith & Nephew, Inc., United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2015-08-30
Record revised 2023-09-07 (version 11)

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

Catalogue Numbers

Catalogue numbers for Legion
Catalogue number Size Status
71434131 In distribution
71442033 In distribution
74452342 In distribution
71434123 In distribution
71441500KT In distribution
74452343 In distribution
71434523 In distribution
71441584 In distribution
71443131 In distribution
71443202 In distribution
71443201 In distribution
71434522 In distribution
71441588 In distribution
71441591 In distribution
71443205 In distribution
71440283 In distribution
71441501KT In distribution
71441504KT In distribution
71434491 In distribution
71441259 In distribution
71430032 In distribution
71442031 In distribution
71430031 In distribution
71434132 In distribution
71434493 In distribution
71441592 In distribution
71442166 In distribution
71434159 In distribution
71434136 In distribution
71442032 In distribution
71434492 In distribution
71434521 In distribution
71434129 In distribution
71443132 In distribution
E0015837-1 In distribution
71441261 In distribution
71434127 In distribution
71441507KT In distribution
71434121 In distribution
71441589 In distribution
71440281 In distribution
71434133 In distribution
71434134 In distribution
71434158 In distribution
71434125 In distribution
71441508KT In distribution
71441502KT In distribution
71434128 In distribution
71443207 In distribution
71434494 In distribution
71434124 In distribution
71443203 In distribution
71434135 In distribution
71430034 In distribution
71434126 In distribution
71440287 In distribution
71442167 In distribution
71933073 In distribution
71443206 In distribution
71440285 In distribution
71441582 In distribution
71441506KT In distribution
71441587 In distribution
71434485 In distribution
71441583 In distribution
71441585 In distribution
71441586 In distribution
71443204 In distribution
71442034 In distribution
71441581 In distribution
71430076 In distribution
71430033 In distribution
71441505KT In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

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