KOENIG TOTAL TOE IMPLANT

Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Koenig Total Toe Implant.

Pre-market Notification Details

Device IDK884561
510k NumberK884561
Device Name:KOENIG TOTAL TOE IMPLANT
ClassificationProsthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactBailey Lipscomb
CorrespondentBailey Lipscomb
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeLZJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-31
Decision Date1989-01-24

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