U2 Total Knee System 2103-2165

GUDID 04719872162384

Femoral trial, CR, #6.5, left

UNITED ORTHOPEDIC CORP.

Knee femur prosthesis trial
Primary Device ID04719872162384
NIH Device Record Key05330c3b-a9ac-44c2-b54b-4329804e335c
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Total Knee System
Version Model Number2103-2165
Catalog Number2103-2165
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872162384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

[04719872162384]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-06-21

On-Brand Devices [U2 Total Knee System]

04719872178750Tibial baseplate driver
04719872178163U2 Knee AiO tibia and inset patella case
04719872178156U2 Knee AiO tibia and onset patella case
04719872178149U2 Knee AiO femur and reusable trial case
04719872178132U2 Knee AiO femur and reusable trial case
04719872178125U2 Knee AiO femur case
04719872178118AiO Case
04719872178101PSA Distal spacer caddy
04719872178095U2 PSA Knee femoral offset case
04719872178064PSA Case #3
04719872178026U2 Knee size 7 case
04719872178019U2 Knee MIS case
04719872177999U2 Knee CMA case
04719872177982U2 Knee case #4
04719872177975U2 Knee case #3
04719872177968Tibial insert trial case
04719872177951U2 Knee case #2
04719872177944U2 Knee case #1
04719872175353U2 Knee MIS case
04719872175339U2 Knee case #5
04719872174370MIS femoral cutting guide, #1
04719872174332Femoral IM alignment guide , 7°, right
04719872171348Tibial insert trial, CR, plained, #0, 13mm
04719872171331Tibial insert trial, CR, plained, #0, 11mm
04719872171324Tibial insert trial, CR, plained, #0, 11mm
04719872171317Tibial insert trial, CR, plained, #0, 9mm
04719872170693Straight stem trial, PSA, Ø23×150mm
04719872170686Straight stem trial, PSA, ψ21 x 150mm
04719872170440Straight stem trial, PSA, φ23×75mm
04719872170433Straight stem trial, PSA, φ21×75mm
04719872170198Straight stem trial, PSA, φ22×100mm
04719872170129Straight stem trial, PSA, φ24×75mm
04719872170112Straight stem trial, PSA, φ22×75mm
04719872169000Tibial insert trial, CR, plained, #1, 13mm
04719872168980Tibial insert trial, CR, plained, #1, 11mm
04719872168966Tibial insert trial, CR, plained, #1, 9mm
04719872168942Tibial insert trial, CR, plained, #0, 18mm
04719872168935Tibial insert trial, CR, plained, #0, 18mm
04719872168928Tibial insert trial, CR, plained, #0, 15mm
04719872168911Tibial insert trial, CR, plained, #0, 15mm
04719872168904Tibial insert trial, CR, plained, #0, 13mm
04719872168898Tibial insert trial, CR, plained, #0, 9mm
04719872168751Tibial baseplate trial, #0
04719872167730MIS femoral A/P chamfer cutting guide,＃5
04719872166399Straight stem trial, PSA, φ23×100mm
04719872166382Straight stem trial, PSA, φ21×100mm
04719872165279Tibial insert trial, PS, #7, 18mm
04719872165255Tibial insert trial, PS, #7, 15mm
04719872165231Tibial insert trial, PS, #7, 13mm
04719872165217Tibial insert trial, PS, #7, 11mm
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