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.

04719872142485 - UTF Hip Stem2025-09-23 UTF Stem case, #3, left
04719872142492 - UTF Hip Stem2025-09-23 UTF Stem case, #3, right
04719872142508 - UTS Hip Stem2025-09-23 UTS Stem case, #3, left
04719872142515 - UTS Hip Stem2025-09-23 UTS Stem case, #3, right
04719872142553 - USTAR II Knee System2025-09-23 USTAR II Yoke adaptor, S, fixed
04719872142560 - USTAR II Knee System2025-09-23 USTAR II Yoke adaptor, M, fixed
04719872143024 - U-Motion II2025-09-23 Acetabular cup trial, 45mm
04719872143031 - U-Motion II2025-09-23 Acetabular cup trial, 47mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.