EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM

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

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for European Style Taper,press-fit Hip Stem.

Pre-market Notification Details

Device IDK062775
510k NumberK062775
Device Name:EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
ContactWilliam J Griffin
CorrespondentWilliam J Griffin
ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-18
Decision Date2007-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00822409011094 K062775 000
00822409010806 K062775 000

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