UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

ARTHROSURFACE, INC.

The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Unicap Unicompartmental Knee Resurfacing Prosthesis.

Pre-market Notification Details

Device IDK050373
510k NumberK050373
Device Name:UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
ContactSteven Ek
CorrespondentSteven Ek
ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-14
Decision Date2005-10-11
Summary:summary

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