U1 HIP SYSTEM - BIPOLAR

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

UNITED ORTHOPEDIC CORP.

The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U1 Hip System - Bipolar.

Pre-market Notification Details

Device IDK050269
510k NumberK050269
Device Name:U1 HIP SYSTEM - BIPOLAR
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu,  TW 300
ContactGene Huang
CorrespondentGene Huang
UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu,  TW 300
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-04
Decision Date2005-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04712602344432 K050269 000
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04711605564892 K050269 000
04711605564885 K050269 000
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04712602344425 K050269 000
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04712602343954 K050269 000
04712602343947 K050269 000
04711605564939 K050269 000
04711605564823 K050269 000

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