HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

ARTHROSURFACE, INC.

The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Hemicap Patello-femoral Resurfacing Prosthesis.

Pre-market Notification Details

Device IDK060127
510k NumberK060127
Device Name:HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
ClassificationProsthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Applicant ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
ContactSteven W Ek
CorrespondentSteven W Ek
ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
Product CodeKRR  
CFR Regulation Number888.3540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-18
Decision Date2006-03-16
Summary:summary

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