ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD

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

ORTHO DEVELOPMENT

The following data is part of a premarket notification filed by Ortho Development with the FDA for Ortho Devlopment Ceramic Femoral Head.

Pre-market Notification Details

Device IDK111936
510k NumberK111936
Device Name:ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. Draper,  UT  84020
ContactTom Haueter
CorrespondentTom Haueter
ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. Draper,  UT  84020
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-08
Decision Date2011-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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