Tahoe Uni Knee System

Femoral Component, Cemented, Grit Blast, 4

Registry build 21.09.26
6manufacturers in China registered for this device type
134catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code HSX
Manufacturer City Province Registered as Device types
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
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74

Record

Regulatory record for Tahoe Uni Knee System
Listed by Shalby Advanced Technologies, Inc., United States
FDA product code HSX
Device type Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class Class 2
Regulation 21 CFR 888.3520
Establishment Contract manufacturer, Contract steriliser, Manufacturer
Record published 2022-01-28

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Tahoe Uni Knee System
Catalogue number Size Status
2060-0-0811 In distribution
2061-0-0309 In distribution
2061-0-0813 In distribution
2061-0-0013 In distribution
2061-0-0514 In distribution
2061-0-0511 In distribution
2060-0-0409 In distribution
2061-0-0414 In distribution
2060-0-0213 In distribution
2060-0-0708 In distribution
2061-0-0113 In distribution
2061-0-0111 In distribution
2061-0-0812 In distribution
2061-0-0808 In distribution
2061-0-0213 In distribution
2060-0-0313 In distribution
2060-0-0512 In distribution
2061-0-0211 In distribution
2060-0-0411 In distribution
2060-0-0814 In distribution
2061-0-0210 In distribution
2060-0-0413 In distribution
2061-0-0608 In distribution
2061-0-0713 In distribution
2061-0-0712 In distribution
2060-0-0610 In distribution
2060-0-0608 In distribution
2060-0-0011 In distribution
2061-0-0010 In distribution
2061-0-0108 In distribution
2060-0-0210 In distribution
2061-0-0411 In distribution
2060-0-0712 In distribution
2060-0-0109 In distribution
2060-0-0310 In distribution
2061-0-0709 In distribution
2061-0-0112 In distribution
2260-0-0004 In distribution
2061-0-0308 In distribution
2061-0-0412 In distribution
2060-0-0508 In distribution
2060-0-0111 In distribution
2060-0-0314 In distribution
2060-0-0412 In distribution
2061-0-0508 In distribution
2060-0-0208 In distribution
2060-0-0711 In distribution
2260-0-0001 In distribution
2060-0-0408 In distribution
2061-0-0208 In distribution
2260-0-0003 In distribution
2060-0-0211 In distribution
2061-0-0810 In distribution
2060-0-0110 In distribution
2061-0-0513 In distribution
2060-0-0112 In distribution
2061-0-0012 In distribution
2061-0-0310 In distribution
2061-0-0110 In distribution
2060-0-0212 In distribution
2061-0-0314 In distribution
2061-0-0811 In distribution
2060-0-0311 In distribution
2060-0-0609 In distribution
2060-0-0813 In distribution
2060-0-0113 In distribution
2061-0-0408 In distribution
2061-0-0609 In distribution
2060-0-0812 In distribution
2060-0-0513 In distribution
2061-0-0214 In distribution
2060-0-0808 In distribution
2061-0-0409 In distribution
2060-0-0514 In distribution
2061-0-0209 In distribution
2061-0-0410 In distribution
2060-0-0414 In distribution
2060-0-0014 In distribution
2060-0-0710 In distribution
2061-0-0814 In distribution
2260-0-0008 In distribution
2061-0-0008 In distribution
2061-0-0011 In distribution
2061-0-0611 In distribution
2060-0-0012 In distribution
2061-0-0711 In distribution
2060-0-0214 In distribution
2061-0-0612 In distribution
2061-0-0613 In distribution
2061-0-0610 In distribution
2060-0-0709 In distribution
2061-0-0311 In distribution
2060-0-0810 In distribution
2060-0-0509 In distribution
2060-0-0114 In distribution
2061-0-0512 In distribution
2061-0-0710 In distribution
2060-0-0309 In distribution
2060-0-0614 In distribution
2060-0-0713 In distribution
2061-0-0109 In distribution
2060-0-0209 In distribution
2061-0-0509 In distribution
2060-0-0108 In distribution
2060-0-0511 In distribution
2060-0-0809 In distribution
2061-0-0614 In distribution
2060-0-0613 In distribution
2260-0-0005 In distribution
2061-0-0413 In distribution
2061-0-0212 In distribution
2061-0-0009 In distribution
2060-0-0714 In distribution
2060-0-0312 In distribution
2060-0-0612 In distribution
2060-0-0410 In distribution
2061-0-0510 In distribution
2061-0-0014 In distribution
2060-0-0009 In distribution
2260-0-0002 In distribution
2060-0-0510 In distribution
2061-0-0114 In distribution
2060-0-0010 In distribution
2061-0-0708 In distribution
2061-0-0809 In distribution
2061-0-0714 In distribution
2061-0-0312 In distribution
2060-0-0008 In distribution
2061-0-0313 In distribution
2060-0-0308 In distribution
2060-0-0013 In distribution
2060-0-0611 In distribution
2260-0-0007 In distribution
2260-0-0006 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Journey Smith & Nephew, Inc. 517
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Ortho Development Corp. 303
BKS® Uni Ortho Development Corp. 240
LinkSymphoKnee Waldemar Link GmbH & Co. KG 210
Moto Partial Knee System Medacta International SA 205
Arthrex® Arthrex, Inc. 199
Stride Smith & Nephew, Inc. 190
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Zimmer, Inc. 175
ZUK Smith & Nephew, Inc. 161
Moto Partial Knee System – Medial Medacta International SA 132
Journey II Smith & Nephew, Inc. 119
Genesis Smith & Nephew, Inc. 118

Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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