U2 ACETABULAR CUP

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

UNITED ORTHOPEDIC CORP.

The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U2 Acetabular Cup.

Pre-market Notification Details

Device IDK022520
510k NumberK022520
Device Name:U2 ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu,  TW 300
ContactJiann-jong Liau
CorrespondentJiann-jong Liau
UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu,  TW 300
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-30
Decision Date2003-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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