HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM

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 Howmedica Kinemax Plus Total Knee System.

Pre-market Notification Details

Device IDK910500
510k NumberK910500
Device Name:HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactRobert E Smith
CorrespondentRobert E Smith
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-05
Decision Date1991-05-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327046755 K910500 000
07613327046717 K910500 000
07613327046700 K910500 000
07613327046694 K910500 000
07613327046670 K910500 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.