UTF STEM-REDUCED, ADDITIONAL SIZES

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

UNITED ORTHOPEDIC CORPORATION

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Utf Stem-reduced, Additional Sizes.

Pre-market Notification Details

Device IDK132207
510k NumberK132207
Device Name:UTF STEM-REDUCED, ADDITIONAL SIZES
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu,  TW 300
ContactFang-yuan Ho
CorrespondentFang-yuan Ho
UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu,  TW 300
Product CodeLPH  
Subsequent Product CodeKWY
Subsequent Product CodeLZO
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-16
Decision Date2013-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719872171270 K132207 000
04711605585330 K132207 000
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04711605585293 K132207 000
04711605585286 K132207 000
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04719886900545 K132207 000
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04711605567497 K132207 000
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04719872171225 K132207 000
04719872167570 K132207 000
04719872167563 K132207 000
04719872157021 K132207 000
04719872157007 K132207 000
04712771505191 K132207 000
04712771505054 K132207 000
04711605567510 K132207 000
04719886900491 K132207 000

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