DURACON INSET PATELLA WITH CENTRAL PEG

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duracon Inset Patella With Central Peg.

Pre-market Notification Details

Device IDK961482
510k NumberK961482
Device Name:DURACON INSET PATELLA WITH CENTRAL PEG
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactMargaret F Crowe
CorrespondentMargaret F Crowe
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-18
Decision Date1996-07-05
Summary:summary

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