ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS

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

ORTHO DEVELOPMENT CORP.

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

Pre-market Notification Details

Device IDK060577
510k NumberK060577
Device Name:ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-06
Decision Date2006-04-28

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