Apex Knee System

EVO Tibial Tray Trial for punch dart w additional mantle sz 3L

Registry build 21.09.26
21manufacturers in China registered for this device type
635catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
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
Canwell Medical Co., Ltd. Jinhua Zhejiang 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
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for Apex Knee System
Listed by Omni Life Science, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
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
XK-11012 In distribution
KR-20003 In distribution
KS-92411 In distribution
KT-44100 In distribution
KT-4510R In distribution
KS-93613 In distribution
KS-91413 In distribution
KT-45050 In distribution
XK-07095 In distribution
KT-0410R In distribution
KS-1465L In distribution
KT-42050 In distribution
WS-2112R-M In distribution
KS-93511 In distribution
KS-44408 In distribution
XK80001 In distribution
KT-4310L In distribution
KS-95316 In distribution
GM-03005-12 In distribution
XN-72311 In distribution
GM-03006-18 In distribution
GM-03005-03 In distribution
KS-1410L In distribution
GM-03005-02 In distribution
WS-2111R In distribution
KR-20006 In distribution
XK-62362 In distribution
KR-45020-R In distribution
XK-0113L In distribution
KS-92212 In distribution
KS-2113R-A In distribution
GM-03006-17 In distribution
KS-1460R In distribution
KS-92620 In distribution
KS-95328 In distribution
KS-94120 In distribution
KT-0025L In distribution
KR-45040 In distribution
KR-45040-R In distribution
KS-92512 In distribution
KS-2116R-A In distribution
KS-94514 In distribution
XK-70945 In distribution
KR-46008 In distribution
KS-93410 In distribution
KS-92613 In distribution
KS-1435L In distribution
KS-95514 In distribution
KS-95312 In distribution
KT-0435R-01 In distribution
WS-2115R In distribution
KT-4105R In distribution
KS-94118 In distribution
GM-03006-09 In distribution
KR-22005 In distribution
KS-92614 In distribution
KT-0020L In distribution
KS-92114 In distribution
KS-91412 In distribution
KS-91112 In distribution
KS-95318 In distribution
KS-2111R-A In distribution
KS-60104 In distribution
KS-40358 In distribution
KS-95114 In distribution
X580-1L In distribution
KT-0425L-01 In distribution
KS-94413 In distribution
WS-2116L In distribution
XK-0123R-M In distribution
KT-07002 In distribution
GM-03061-04 In distribution
KS-95410 In distribution
KT-0565R In distribution
GM-03005-11 In distribution
KR-45020 In distribution
KS-95324 In distribution
XK-10220 In distribution
KS-92610 In distribution
KR-20016 In distribution
KS-92316 In distribution
KT-0445R In distribution
KS-44116 In distribution
KT-0045L In distribution
GM-03005-04 In distribution
XK-11007 In distribution
KR-20001 In distribution
XK-11006 In distribution
GM-03061-09 In distribution
KS-93110 In distribution
KS-94116 In distribution
KT-41050 In distribution
KS-94112 In distribution
KT-0415L In distribution
KS-44111 In distribution
KT-31100 In distribution
KS-2116L-A In distribution
XK-10221 In distribution
KR-46020 In distribution
KS-44114 In distribution
KT-4205R In distribution
XK-0124R-M In distribution
KS-93618 In distribution
GM16001-301-2L In distribution
KT-4115L In distribution
KS-93210 In distribution
KR-22003 In distribution
KS-44120 In distribution
KS-91113 In distribution
GM16001-301-3R In distribution
KS-95418 In distribution
XK-10211 In distribution
KS-1445R In distribution
KT-0045R In distribution
KT-0445L-01 In distribution
KS-94211 In distribution
XK-0111L In distribution
KS-44420 In distribution
GM16001-301-5R In distribution
KS-67106 In distribution
KS-95511 In distribution
KT-4415R In distribution
KS-40320 In distribution
KS-1425L In distribution
WS-60024 In distribution
KS-93620 In distribution
KR-45060 In distribution
KR-46012 In distribution
KS-95128 In distribution
XK-07175 In distribution
KS-93318 In distribution
KR-21004 In distribution
KT-0455L In distribution
XK-11011 In distribution
KS-93610 In distribution
KT-0410L In distribution
KS-94516 In distribution
XK-50020 In distribution
KS-94310 In distribution
XK-0116R In distribution
GM-03061-02 In distribution
KS-91611 In distribution
KS-92510 In distribution
KS-94213 In distribution
XK-70942 In distribution
KT-4210L In distribution
KS-44414 In distribution
KR-21005 In distribution
KS-93310 In distribution
KS-92320 In distribution
KR-22004 In distribution
KR-46004 In distribution
KS-94612 In distribution
GM-03005-05 In distribution
KS-95124 In distribution
KT-0415R-01 In distribution
KS-95518 In distribution
KS-93212 In distribution
KS-93113 In distribution
KT-0435L In distribution
KS-93116 In distribution
XK-0121L-M In distribution
KS-92118 In distribution
WS-2111R-M In distribution
KT-0410L-01 In distribution
XK-67731 In distribution
X580-3L In distribution
GM16001-301-4R In distribution
KS-67044 In distribution
KS-1440L In distribution
KS-91512 In distribution
XK-5021L In distribution
KS-95228 In distribution
KS-94513 In distribution
X580-2L In distribution
KS-94412 In distribution
KT-42101 In distribution
KS-40380 In distribution
X580-3R In distribution
KT-43101 In distribution
KS-94210 In distribution
KS-92520 In distribution
KR-46060 In distribution
KS-95412 In distribution
WS-2111L In distribution
KS-91313 In distribution
X580-6L In distribution
KS-95414 In distribution
KS-92213 In distribution
KT-4305L In distribution
KR-45010-R In distribution
WS-2113L-M In distribution
XK-0112L In distribution
KS-2112L-A In distribution
KS-94414 In distribution
KS-95224 In distribution
XK-0126L-M In distribution
WS-2116R In distribution
X580-4L In distribution
KS-95320 In distribution
KS-92211 In distribution
WS-2113L In distribution
KS-95220 In distribution
KS-92111 In distribution
KS-94216 In distribution
KS-92611 In distribution
KS-93120 In distribution
KS-95428 In distribution
KS-91116 In distribution
KS-91114 In distribution
KR-45010 In distribution
XK-11009 In distribution
GM-03061-12 In distribution
XK-50017 In distribution
KS-92314 In distribution
KS-92412 In distribution
GM-03061-10 In distribution
KS-94611 In distribution
KS-94410 In distribution
XK-5021R In distribution
KS-94320 In distribution
KT-43050 In distribution
KS-92413 In distribution
XK80002 In distribution
KS-91213 In distribution
KS-91214 In distribution
KS-44418 In distribution
XK-5024R In distribution
GM-03006-08 In distribution
KS-95112 In distribution
KS-91416 In distribution
KS-91212 In distribution
KT-4505L In distribution
KT-0415L-01 In distribution
KS-44410 In distribution
KR-45050 In distribution
KR-22002 In distribution
GM-03005-09 In distribution
KS-93516 In distribution
KS-91614 In distribution
KS-95210 In distribution
KS-93413 In distribution
XK-5023R In distribution
XK-50015 In distribution
XK-10210 In distribution
KT-4510L In distribution
KS-94411 In distribution
KS-92513 In distribution
KT-0010R In distribution
GM-03006-02 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 447

Showing 12 of 2,940. All products under Template

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