KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEM

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

KIRSCHNER MEDICAL CORP.

The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Proximal Femur Total Hip System.

Pre-market Notification Details

Device IDK861826
510k NumberK861826
Device Name:KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEM
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
ContactSam Son
CorrespondentSam Son
KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
Product Code510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-12
Decision Date1986-08-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304268975 K861826 000
00880304268890 K861826 000
00880304268906 K861826 000
00880304268913 K861826 000
00880304268920 K861826 000
00880304268937 K861826 000
00880304268944 K861826 000
00880304268951 K861826 000
00880304268968 K861826 000
00880304268883 K861826 000

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