Evolution®

Evolution Tibial Cones Tibial Prep Instrument Tray

Registry build 21.09.26
105manufacturers in China registered for this device type
108catalogue 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 Evolution®
Listed by Microport Orthopedics Inc., United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-12-30
Record revised 2018-03-29 (version 2)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for Evolution®
Catalogue number Size Status
ES005018 In distribution
ES001004 In distribution
ES005007 In distribution
ES001036 In distribution
ESMPOJ75 In distribution
ES001037 In distribution
ES001014 In distribution
ES001008 In distribution
ES002003 In distribution
ES001030 In distribution
KS30TR78 In distribution
ES001003 In distribution
ES005003 In distribution
ES001040 In distribution
ES00TR73 In distribution
KS30CTR8 In distribution
ES001024 In distribution
KS30PTR7 In distribution
ES001044 In distribution
KS30RTR1 In distribution
ES005002 In distribution
ES001005 In distribution
ESMPOJ30 In distribution
ES00TR72 In distribution
ES005001 In distribution
ES001045 In distribution
ES001032 In distribution
KS30CTR6 In distribution
ES001035 In distribution
ES001018 In distribution
ES001029 In distribution
ES005005 In distribution
ES001020 In distribution
KS30CTR2 In distribution
ES001021 In distribution
ES001002 In distribution
ES005019 In distribution
ES001027 In distribution
ES001010 In distribution
ES001031 In distribution
ESMPOJ31 In distribution
ESMPOJ29 In distribution
ES001042 In distribution
ES001025 In distribution
ES001028 In distribution
E400TR45 In distribution
KS30CTR1 In distribution
ES005008 In distribution
ES001017 In distribution
KS30CTR3 In distribution
ESMPOJ21 In distribution
KS30RTR2 In distribution
ES001009 In distribution
ES001023 In distribution
ESMPOJ27 In distribution
KS30PTR1 In distribution
ESMPOJ01 In distribution
KS30RTR3 In distribution
KS30CTR4 In distribution
ES001022 In distribution
E5010001 In distribution
KS30PTR5 In distribution
ES001011 In distribution
ES001033 In distribution
ES001041 In distribution
ES005006 In distribution
KS30PTR8 In distribution
KS30TR56 In distribution
ES00TR74 In distribution
ESMPOJ06 In distribution
ES001006 In distribution
E400TR44 In distribution
KS30CTR7 In distribution
ES00TR71 In distribution
KS30FTR1 In distribution
ESMPOJ07 In distribution
ES001050 In distribution
ES001106 In distribution
ES001007 In distribution
ES001026 In distribution
ES001043 In distribution
ES002002 In distribution
KS30PTR2 In distribution
ES001001 In distribution
EAT2001R In distribution
ESMPOJ20 In distribution
ES002001 In distribution
KS30PTR6 In distribution
ES001019 In distribution
KS30PTR4 In distribution
EAT2001L In distribution
ESMPOJ32 In distribution
ES001016 In distribution
ES001015 In distribution
ES001012 In distribution
ES001013 In distribution
ES001000 In distribution
KS30CTR5 In distribution
ES001034 In distribution
ES00TR70 In distribution
KS30NTR1 In distribution
KS30TR34 In distribution
ES005004 In distribution
ES001039 In distribution
ES005017 In distribution
KS30PTR3 In distribution
ES005016 In distribution
ES001103 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