Genflex2 Total Knee System

GENflex2 CR Ultra-Congruent Tibial Insert, EXp, Size 2.5-15

Registry build 21.09.26
8manufacturers in China registered for this device type
389catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OIY
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
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34

Record

Regulatory record for Genflex2 Total Knee System
Listed by Globus Medical, Inc., United States
FDA product code OIY
Device type Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device class Class 2
Regulation 21 CFR 888.3560
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-20
Record revised 2020-12-11 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Genflex2 Total Knee System
Catalogue number Size Status
SC3751-4.5 In distribution
SC3802-2-17 In distribution
SC3916-1-10 In distribution
SC3802-5-23 In distribution
SC3754-1.5-14 In distribution
SC3803-3.5-23 In distribution
SC3753-5-14 In distribution
SC3802-3.5-30 In distribution
SC3753-3.5-16 In distribution
SC3753-4.5-10 In distribution
SC3916-4-15 In distribution
SC3753-1.5-11 In distribution
SC3802-3.5-23 In distribution
SC3753-2-12 In distribution
SC3752-6 In distribution
SC3754-2-12 In distribution
SC3916-3-16 In distribution
SC3753-6-26 In distribution
SC3916-2-26 In distribution
SC3802-2.5-11 In distribution
SC3916-2.5-15 In distribution
SC3754-3.5-20 In distribution
SC3916-2.5-10 In distribution
SC3858-3.5 In distribution
SC3753-3.5-14 In distribution
SC3754-1.5-20 In distribution
SC3916-4.5-23 In distribution
SC3753-6-12 In distribution
SC3916-6-30 In distribution
SC3754-6-14 In distribution
SC3754-5-14 In distribution
SC3916-2-13 In distribution
SC3802-5-30 In distribution
SC3916-5-23 In distribution
SC3754-3.5-10 In distribution
SC3916-4.5-14 In distribution
SC3753-2-16 In distribution
SC3803-3.5-30 In distribution
SC3916-3.5-26 In distribution
SC3754-4-12 In distribution
SC3916-2.5-11 In distribution
SC3754-5-20 In distribution
SC3803-1-15 In distribution
SC3802-1-12 In distribution
SC3802-1.5-10 In distribution
SC3916-6-17 In distribution
SC3916-4-10 In distribution
SC3916-4.5-20 In distribution
SC3802-3.5-15 In distribution
SC3803-6-13 In distribution
SC3916-6-13 In distribution
SC3916-5-20 In distribution
SC3802-6-15 In distribution
SC3753-4.5-26 In distribution
SC3754-6-26 In distribution
SC3754-4-16 In distribution
SC3749-2.5 In distribution
SC3802-4-11 In distribution
SC3916-1-15 In distribution
SC3754-4-20 In distribution
SC3916-6-16 In distribution
SC3754-3-14 In distribution
SC3753-2.5-14 In distribution
SC3803-1.5-15 In distribution
SC3750-1.5 In distribution
SC3802-3.5-17 In distribution
SC3916-2.5-20 In distribution
SC3754-3-16 In distribution
SC3802-4.5-30 In distribution
SC3802-1.5-12 In distribution
SC3802-4-15 In distribution
SC3753-2.5-16 In distribution
SC3803-2.5-14 In distribution
SC3916-4.5-10 In distribution
SC3802-4-13 In distribution
SC3916-5-11 In distribution
SC3752-4.5 In distribution
SC3916-1-14 In distribution
SC3916-1-20 In distribution
SC3916-1-12 In distribution
SC3916-1.5-15 In distribution
SC3803-5-23 In distribution
SC3802-1-30 In distribution
SC3802-2-30 In distribution
SC3802-2.5-30 In distribution
SC3916-3.5-20 In distribution
SC3916-3.5-12 In distribution
SC3803-3.5-11 In distribution
SC3857-3.5 In distribution
SC3916-3-11 In distribution
SC3754-1-14 In distribution
SC3916-1.5-26 In distribution
SC3753-1-11 In distribution
SC3754-5-12 In distribution
SC3753-5-20 In distribution
SC3916-3-26 In distribution
SC3916-4.5-16 In distribution
SC3916-5-13 In distribution
SC3754-2-14 In distribution
SC3753-4-14 In distribution
SC3916-2-30 In distribution
SC3802-1.5-26 In distribution
SC3916-3-20 In distribution
SC3803-1-23 In distribution
SC3754-4.5-14 In distribution
SC3803-3-30 In distribution
SC3803-6-23 In distribution
SC3916-1.5-11 In distribution
SC3916-4-16 In distribution
SC3754-1-12 In distribution
SC3803-3.5-17 In distribution
SC3754-2.5-14 In distribution
SC3803-5-15 In distribution
SC3803-4.5-13 In distribution
SC3802-1-14 In distribution
SC3751-3.5 In distribution
SC3803-2-13 In distribution
SC3753-3.5-12 In distribution
SC3749-6 In distribution
SC3802-4.5-23 In distribution
SC3916-3-15 In distribution
SC3753-3.5-20 In distribution
SC3749-4.5 In distribution
SC3753-2-20 In distribution
SC3802-5-17 In distribution
SC3802-1.5-16 In distribution
SC3803-4-11 In distribution
SC3754-3.5-16 In distribution
SC3752-3.5 In distribution
SC3858-2.5 In distribution
SC3802-4.5-13 In distribution
SC3753-2.5-12 In distribution
SC3803-2-17 In distribution
SC3802-1-10 In distribution
SC3754-1-16 In distribution
SC3802-3-13 In distribution
SC3754-1.5-12 In distribution
SC3753-3-10 In distribution
SC3802-3-23 In distribution
SC3754-1-26 In distribution
SC3803-1.5-23 In distribution
SC3916-1.5-23 In distribution
SC3751-2.5 In distribution
SC3752-1.5 In distribution
SC3802-6-13 In distribution
SC3802-4.5-15 In distribution
SC3916-1.5-10 In distribution
SC3916-3.5-13 In distribution
SC3916-1-26 In distribution
SC3802-2-11 In distribution
SC3754-3-20 In distribution
SC3753-4-12 In distribution
SC3802-2-23 In distribution
SC3753-5-26 In distribution
SC3802-3-15 In distribution
SC3803-2-15 In distribution
SC3857-4.5 In distribution
SC3753-4.5-20 In distribution
SC3916-1.5-17 In distribution
SC3753-3-16 In distribution
SC3803-6-15 In distribution
SC3803-2-23 In distribution
SC3754-4.5-12 In distribution
SC3754-4.5-20 In distribution
SC3753-6-20 In distribution
SC3753-1-13 In distribution
SC3803-2.5-16 In distribution
SC3803-1.5-30 In distribution
SC3803-4.5-17 In distribution
SC3857-2.5 In distribution
SC3754-2.5-26 In distribution
SC3916-2-12 In distribution
SC3754-1-20 In distribution
SC3916-3.5-30 In distribution
SC3753-5-12 In distribution
SC3802-3-30 In distribution
SC3753-4.5-16 In distribution
SC3803-1.5-11 In distribution
SC3803-5-11 In distribution
SC3754-2.5-12 In distribution
SC3753-4-10 In distribution
SC3753-4.5-12 In distribution
SC3916-6-20 In distribution
SC3916-6-23 In distribution
SC3916-4.5-26 In distribution
SC3753-1.5-15 In distribution
SC3753-4-26 In distribution
SC3803-2.5-11 In distribution
SC3916-4.5-11 In distribution
SC3749-1 In distribution
SC3751-6 In distribution
SC3916-3.5-11 In distribution
SC3916-2-20 In distribution
SC3916-3-10 In distribution
SC3752-2.5 In distribution
SC3916-1-13 In distribution
SC3802-1-23 In distribution
SC3754-4-10 In distribution
SC3803-1-30 In distribution
SC3916-6-14 In distribution
SC3803-3.5-15 In distribution
SC3916-1-23 In distribution
SC3754-5-16 In distribution
SC3802-6-30 In distribution
SC3803-6-30 In distribution
SC3802-2.5-15 In distribution
SC3916-1-16 In distribution
SC3753-6-16 In distribution
SC3802-4.5-11 In distribution
SC3803-5-30 In distribution
SC3753-5-16 In distribution
SC3802-2-15 In distribution
SC3858-4.5 In distribution
SC3803-1-17 In distribution
SC3803-1-11 In distribution
SC3916-5-14 In distribution
SC3803-2.5-26 In distribution
SC3916-2-10 In distribution
SC3751-1.5 In distribution
SC3916-2.5-30 In distribution
SC3754-2-26 In distribution
SC3754-6-20 In distribution
SC3754-3-12 In distribution
SC3916-3.5-10 In distribution
SC3916-6-26 In distribution
SC3753-1.5-23 In distribution
SC3802-6-17 In distribution
SC3802-2.5-23 In distribution
SC3803-4-17 In distribution
SC3916-2-14 In distribution
SC3916-2-15 In distribution
SC3754-3-26 In distribution
SC3753-3.5-26 In distribution
SC3753-3-14 In distribution
SC3802-4-23 In distribution
SC3916-3-12 In distribution
SC3916-3-13 In distribution
SC3803-2.5-20 In distribution
SC3802-1-16 In distribution
SC3802-4-17 In distribution
SC3802-4-30 In distribution
SC3916-5-10 In distribution
SC3754-2-16 In distribution
SC3753-2.5-10 In distribution
SC3916-3.5-23 In distribution
SC3754-3.5-12 In distribution
SC3916-4-11 In distribution
SC3802-5-11 In distribution
SC3803-5-13 In distribution
SC3916-2.5-16 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Persona® Zimmer, Inc. 552
DJO Surgical Encore Medical, L.P. 415
Persona® Vivacit-E® Zimmer, Inc. 332
Truliant, Activit-E Exactech, Inc. 272
TriVerse Meniscal Insert PS Signature Orthopaedics PTY Limited 220
U2™ Knee United Orthopedic Corp. 195
BKS E-Vitalize Ortho Development Corp. 193
Vanguard XP Instrumentation Biomet Orthopedics 169
Attune Depuy (Ireland) 161
Vanguard Complete Knee System Biomet Orthopedics 153
EXp Tibial Inserts and Patellar Components Globus Medical, Inc. 144
TriVerse Meniscal Insert AS Signature Orthopaedics PTY Limited 126

Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

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