UTF Stem, reduced, Ti plasma spray, high offset 1106-3200

GUDID 04712771504941

UTF Stem, reduced, Ti plasma spray, high offset, #0

UNITED ORTHOPEDIC CORP.

Revision coated hip femur prosthesis
Primary Device ID04712771504941
NIH Device Record Key3fcce6d6-d910-4fc3-9d0b-9b54d052670d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUTF Stem, reduced, Ti plasma spray, high offset
Version Model Number1106-3200
Catalog Number1106-3200
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104712771504941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-06
Device Publish Date2017-10-06

Devices Manufactured by UNITED ORTHOPEDIC CORP.

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04719886910650 - UTF Hip Stem 2025-11-21 UTF-r Femoral broach tray
04719886910667 - UTF Hip Stem 2025-11-21 UTF-r Femoral prep tray
04719886910674 - UTF Hip Stem 2025-11-21 UTF-r Straight/offset tray
04719886910681 - UTF Hip Stem 2025-11-21 UTF-r Dual offset tray
04719886910698 - UTF Hip Stem 2025-11-21 United femoral head trial tray

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