POLARCUP DUAL MOBILITY SYSTEM

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

PLUS ORTHOPEDICS AG

The following data is part of a premarket notification filed by Plus Orthopedics Ag with the FDA for Polarcup Dual Mobility System.

Pre-market Notification Details

Device IDK070278
510k NumberK070278
Device Name:POLARCUP DUAL MOBILITY SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk,  MA  02056
ContactPamela J Weagraff
CorrespondentPamela J Weagraff
PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk,  MA  02056
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-29
Decision Date2007-04-16
Summary:summary

NIH GUDID Devices

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