U2 HIP STEM, TI POROUS COATED

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 Hip Stem, Ti Porous Coated.

Pre-market Notification Details

Device IDK003237
510k NumberK003237
Device Name:U2 HIP STEM, TI POROUS COATED
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu,  TW 300
ContactMellen Liu
CorrespondentMellen Liu
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 Received2000-10-17
Decision Date2001-01-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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