USTAR II Knee System

GUDID 04711605588812

Tibial augment trial, #6, 5mm, left

UNITED ORTHOPEDIC CORP.

Knee femur prosthesis trial
Primary Device ID04711605588812
NIH Device Record Keybbbd2a46-61ea-455b-8dc5-3cbc994c61de
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSTAR II Knee System
Version Model Number2815-2161
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 Identifiers

Device Issuing AgencyDevice ID
GS104711605588812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, Hip, Hemi-, Femoral, Metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


[04711605588812]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-03
Device Publish Date2019-12-26

Devices Manufactured by UNITED ORTHOPEDIC CORP.

04719886910544 - USTAR II Knee System2025-07-24 A/P offset guide
04719886909111 - U2 Total Knee System2025-07-22 Femoral distal augment trial, left medial/right lateral, #2, 4mm
04719886909128 - U2 Total Knee System2025-07-22 Femoral distal augment trial, left medial/right lateral, #2, 8mm
04719886909135 - U2 Total Knee System2025-07-22 Femoral distal augment trial, left medial/right lateral, #2, 12mm
04719886909142 - U2 Total Knee System2025-07-22 Femoral distal augment trial, left medial/right lateral, #2, 16mm
04719886909159 - U2 Total Knee System2025-07-22 Femoral distal augment trial, right medial/left lateral, #2, 4mm
04719886909166 - U2 Total Knee System2025-07-22 Femoral distal augment trial, right medial/left lateral, #2, 8mm
04719886909173 - U2 Total Knee System2025-07-22 Femoral distal augment trial, right medial/left lateral, #2, 12mm

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