DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS

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 Duration Stabilized Uhmwpe Knee Comp., Wear Claims.

Pre-market Notification Details

Device IDK972864
510k NumberK972864
Device Name:DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactFrank Maas
CorrespondentFrank Maas
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-04
Decision Date1997-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327047738 K972864 000
07613327047660 K972864 000
07613327047448 K972864 000

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