HEMISPHERE MODULAR CUP SYSTEM

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 Hemisphere Modular Cup System.

Pre-market Notification Details

Device IDK000321
510k NumberK000321
Device Name:HEMISPHERE MODULAR CUP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper,  UT  84020
ContactCarol Freasier
CorrespondentCarol Freasier
ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper,  UT  84020
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-02
Decision Date2000-04-10

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