Apex Knee System

iBlock mounted saw cutting guide for fem augment resection

Registry build 21.09.26
26manufacturers in China registered for this device type
272catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZX
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13

Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument

Record

Regulatory record for Apex Knee System
Listed by Omni Life Science, Inc., United States
FDA product code FZX
Device type Guide, 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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Apex Knee System
Catalogue number Size Status
KS-70002 In distribution
KS-81001 In distribution
KS-66025A In distribution
GM-03007-08 In distribution
XK-00134 In distribution
GM-03007-04 In distribution
KS-67015 In distribution
WS-10003 In distribution
800001 In distribution
WS-30076 In distribution
KS-9016L In distribution
KS-90030 In distribution
KS-60300 In distribution
WS-10006A In distribution
KS-9013L In distribution
KS-62004 In distribution
KS-67041 In distribution
KS-66025R In distribution
XK-60580 In distribution
WS-10001 In distribution
WS-10006 In distribution
KR-40000 In distribution
KS-60101 In distribution
KS-66021 In distribution
KS-90104 In distribution
KS-99017 In distribution
KS-9015L In distribution
WS-40001 In distribution
KS-67042 In distribution
WS-10002A In distribution
KS-90015 In distribution
XK-00174 In distribution
XK-07180 In distribution
KR-22000 In distribution
KS-29511 In distribution
KS-29514 In distribution
KS-99202 In distribution
XK-07257 In distribution
XK-66021 In distribution
KS-90101 In distribution
XK-06587 In distribution
KR-50266 In distribution
KS-67048 In distribution
KS-66023 In distribution
KS-40500 In distribution
KS-66026 In distribution
KS-90103 In distribution
XK-66023 In distribution
WS-40071 In distribution
KS-70001 In distribution
X821-00 In distribution
WS-40070 In distribution
KS-90016 In distribution
KS-67024 In distribution
XK-00166 In distribution
KS-67026 In distribution
KT-08003 In distribution
KS-67052 In distribution
WS-10050 In distribution
XK-00082 In distribution
KS-90037 In distribution
KS-67104 In distribution
XK-07172 In distribution
GM-03007-06 In distribution
XK-00238 In distribution
XK-00066 In distribution
KS-67022 In distribution
XK-03032 In distribution
KS-9011R In distribution
XK-50011 In distribution
XK-00122 In distribution
WS-10059 In distribution
XK-03029 In distribution
KS-61001 In distribution
XK-62180 In distribution
XK-06778 In distribution
GM-03007-01 In distribution
XK-00121 In distribution
GM-03007-02 In distribution
KS-66021A In distribution
KS-9014R In distribution
KS-90105 In distribution
KS-90032 In distribution
KS-67100 In distribution
WS-10001A In distribution
KS-66022R In distribution
XK-07036 In distribution
XK-00124 In distribution
XK-06789 In distribution
XK-66025 In distribution
XK-07126 In distribution
KS-67031 In distribution
XK-70162 In distribution
XK-00234 In distribution
KS-81002 In distribution
KS-66022 In distribution
WS-10071 In distribution
XK-58075 In distribution
WS-40138 In distribution
KS-9017L In distribution
KS-29512 In distribution
GM-03007-07 In distribution
XK-06519 In distribution
XK-00084 In distribution
KS-72001 In distribution
WS-20081 In distribution
WS-10003A In distribution
KS-69010 In distribution
KS-67105 In distribution
KS-29513 In distribution
KS-66021R In distribution
KS-60100 In distribution
XK-00233 In distribution
XN-07215 In distribution
XK-00164 In distribution
XK-70244 In distribution
KR-55000 In distribution
XK-50010 In distribution
KS-90031 In distribution
KS-67102 In distribution
XK-10108 In distribution
WS-20082 In distribution
KR-50001 In distribution
KS-62002 In distribution
XK-06792 In distribution
KS-69001 In distribution
KS-99232 In distribution
XK-00123 In distribution
KS-9015R In distribution
XK-00162 In distribution
XK-00018 In distribution
WS-40002 In distribution
KT-08001 In distribution
XK-00125 In distribution
WS-10005 In distribution
KS-29516 In distribution
XK-70166 In distribution
WS-10005A In distribution
XK-00228 In distribution
XK-03035 In distribution
KS-99230 In distribution
KS-66023A In distribution
XK-00146 In distribution
XK-00044 In distribution
KS-70019 In distribution
KS-67035 In distribution
XK-10107 In distribution
KS-66024R In distribution
KS-9011L In distribution
KS-67014 In distribution
KS-62001 In distribution
KS-90107 In distribution
KS-70000 In distribution
KS-62003 In distribution
KS-29510 In distribution
KS-67034 In distribution
XK-00145 In distribution
XK-66024 In distribution
XK-06184 In distribution
KS-67012 In distribution
KS-67019 In distribution
WS-10004A In distribution
WS-10020 In distribution
KS-66023R In distribution
KR-71306 In distribution
KS-9014L In distribution
KS-62006 In distribution
WS-40020 In distribution
GM-03007-05 In distribution
KS-9013R In distribution
KS-67046 In distribution
KR-50004 In distribution
KS-62005 In distribution
KS-67047 In distribution
XK-00161 In distribution
XK-60540 In distribution
700101 In distribution
WS-10052 In distribution
KI-CEQP0-12-14 In distribution
KS-67033 In distribution
KS-90106 In distribution
XK-06790 In distribution
KS-66025 In distribution
XK-00175 In distribution
XK-66026 In distribution
KS-72000 In distribution
XK-00235 In distribution
GM-03007-03 In distribution
WS-20123 In distribution
XK-70164 In distribution
KS-60103 In distribution
XK-03026 In distribution
XK-03038 In distribution
KS-71008 In distribution
KS-67036 In distribution
800000 In distribution
KS-90029 In distribution
KS-67011 In distribution
WS-40126 In distribution
XK-00173 In distribution
KS-99201 In distribution
KR-70020 In distribution
KS-66024 In distribution
KS-9016R In distribution
XK-00032 In distribution
KS-66024A In distribution
KT-08002 In distribution
XK-00227 In distribution
WS-10069 In distribution
XK-03041 In distribution
XK-00170 In distribution
XK-00171 In distribution
XK-07040 In distribution
KS-70003 In distribution
GM-03007-09 In distribution
KS-90102 In distribution
WS-10068 In distribution
XK-00085 In distribution
KS-67016 In distribution
KS-61200 In distribution
KS-9017R In distribution
XK-15380 In distribution
KS-67107 In distribution
XK-66022 In distribution
XK-10109 In distribution
KS-66022A In distribution
XK-00165 In distribution
X557-00 In distribution
WS-40132 In distribution
XK-70242 In distribution
KS-67108 In distribution
XK-00163 In distribution
KS-69000 In distribution
XK-06567 In distribution
XK-00086 In distribution
WS-40132R In distribution
XK-06582 In distribution
XK-00230 In distribution
XK-00231 In distribution
KS-67032 In distribution
KR-50007 In distribution
WS-20076 In distribution
WS-10067 In distribution
KS-66026A In distribution
KR-50002 In distribution
KS-9012R In distribution
KS-9012L In distribution
KS-29518 In distribution
KS-29508 In distribution
XK-00172 In distribution

Showing 250 of 272 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DJO Surgical Encore Medical, L.P. 2,141
Guide, Surgical, Instrument Synthes Gmbh 727
DJO Surgical DJO, LLC 284
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 223
Motoband CP Crossroads Extremity Systems LLC 221
Advance® Microport Orthopedics Inc. 199
NexGen® Zimmer, Inc. 194
Evolution® Microport Orthopedics Inc. 173
Innomed, Inc. Innomed, Inc. 172
Newclip Instruments Newclip Technics SAS 144
Guide, Surgical, Instrument Zimmer, Inc. 135
Natural Knee® Zimmer, Inc. 134

Showing 12 of 1,788. All products under Guide, 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