36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for 36mm V40 Femoral Head Components (lfit And Non-lfit).

Pre-market Notification Details

Device IDK022077
510k NumberK022077
Device Name:36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactJennifer A Daudelin
CorrespondentJennifer A Daudelin
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeJDI  
Subsequent Product CodeKWY
Subsequent Product CodeLWJ
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-26
Decision Date2002-07-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327032321 K022077 000
07613327032314 K022077 000
07613327032307 K022077 000
07613327032291 K022077 000

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