WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM

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

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc Ii Unicondylar Knee System.

Pre-market Notification Details

Device IDK881779
510k NumberK881779
Device Name:WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactLipscomb, Phd
CorrespondentLipscomb, Phd
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-26
Decision Date1988-08-31

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