Apex Knee System

Apex Revision Knee System - Revision Tibia Reamers and Pilot Stems Pan Insert

Registry build 21.09.26
105manufacturers in China registered for this device type
135catalogue 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 Apex Knee System
Listed by Omni Life Science, Inc., United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2023-01-10

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 Apex Knee System
Catalogue number Size Status
KS-99917 In distribution
KS-90095 In distribution
KS-90074 In distribution
WS-60013 In distribution
KS-90070-IN In distribution
KS-90078-IN In distribution
KS-90092 In distribution
WS-60003 In distribution
KS-90080-IN In distribution
WS-60010 In distribution
KS-90192 In distribution
KS-99181 In distribution
KS-99170 In distribution
KS-90086-IN In distribution
KS-90072 In distribution
WS-60020 In distribution
KS-99918 In distribution
KS-99902 In distribution
KS-90191 In distribution
KS-99021 In distribution
WS-60017 In distribution
KS-99180 In distribution
KS-99165 In distribution
KS-99921 In distribution
KS-90191-IN In distribution
GM16001-304-00 In distribution
KS-90083 In distribution
KS-90083-IN In distribution
KS-99168 In distribution
WS-60001 In distribution
KS-90084 In distribution
KS-90095-IN In distribution
KS-90192-IN In distribution
KS-90193 In distribution
KS-99100 In distribution
KS-99104 In distribution
KS-90073-IN In distribution
KS-99103 In distribution
KS-90081 In distribution
KS-90108-IN In distribution
KS-90085-IN In distribution
KS-90075-IN In distribution
WS-60016 In distribution
KS-90071-IN In distribution
WS-60011 In distribution
KS-90077-IN In distribution
KS-61107-IN In distribution
WS-60004 In distribution
KS-90070 In distribution
KS-90082-IN In distribution
KS-99162 In distribution
KS-99101 In distribution
KS-99023 In distribution
WS-60008 In distribution
KS-99900 In distribution
KS-99169 In distribution
KS-99260 In distribution
KS-90096 In distribution
WS-60007 In distribution
KS-99090 In distribution
KS-90088-IN In distribution
KS-90088 In distribution
KS-99185 In distribution
KS-90072-IN In distribution
KS-61107 In distribution
KS-99020 In distribution
KS-90108 In distribution
KS-90078 In distribution
WS-60009 In distribution
KS-99102 In distribution
KS-99022 In distribution
KS-99176 In distribution
KS-99164 In distribution
KS-99917-IN In distribution
KS-99918-IN In distribution
KS-90096-IN In distribution
KS-90089 In distribution
KS-99175 In distribution
KS-99173 In distribution
KS-99189 In distribution
KS-99166 In distribution
990003 In distribution
KS-99003 In distribution
KS-99190 In distribution
KS-90081-IN In distribution
WS-60018 In distribution
KS-90091-IN In distribution
KS-90075 In distribution
KS-90094-IN In distribution
KS-99186 In distribution
KS-90091 In distribution
WS-60006 In distribution
KS-90087 In distribution
KS-99901 In distribution
KS-99183 In distribution
KS-99182 In distribution
KS-90074-IN In distribution
KS-90193-IN In distribution
KS-90093-IN In distribution
KS-90090-IN In distribution
KS-90082 In distribution
KS-99174 In distribution
WS-60000 In distribution
KS-90089-IN In distribution
KS-99184 In distribution
KS-90079 In distribution
KS-99188 In distribution
WS-60005 In distribution
KS-90086 In distribution
KS-90090 In distribution
KS-90073 In distribution
KS-90094 In distribution
KS-90077 In distribution
KS-99004 In distribution
KS-90076 In distribution
KS-90071 In distribution
KS-99172 In distribution
KS-90084-IN In distribution
KS-99171 In distribution
KS-99261 In distribution
KS-90092-IN In distribution
KS-90079-IN In distribution
KS-90076-IN In distribution
WS-60021 In distribution
WS-60012 In distribution
WS-60014 In distribution
KS-99163 In distribution
KS-99091 In distribution
KS-90080 In distribution
KS-99203 In distribution
KS-99187 In distribution
KS-90085 In distribution
KS-90093 In distribution
WS-60002 In distribution
WS-60019 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