KINEMATIC II REPLACEMENT TIBIAL INSERTS

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 Kinematic Ii Replacement Tibial Inserts.

Pre-market Notification Details

Device IDK960976
510k NumberK960976
Device Name:KINEMATIC II REPLACEMENT TIBIAL INSERTS
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 For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-11
Decision Date1996-08-07
Summary:summary

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