U-MOTION II PS+ CUP

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

UNITED ORTHOPEDIC CORP.

The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U-motion Ii Ps+ Cup.

Pre-market Notification Details

Device IDK132455
510k NumberK132455
Device Name:U-MOTION II PS+ CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant UNITED ORTHOPEDIC CORP. NO 57, PARK AVE. 2, SCIENCE PARK Hsinchu,  TW 300
ContactFang-yuan Ho
CorrespondentFang-yuan Ho
UNITED ORTHOPEDIC CORP. NO 57, PARK AVE. 2, SCIENCE PARK Hsinchu,  TW 300
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeLWJ
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-06
Decision Date2013-09-03
Summary:summary

NIH GUDID Devices

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