MODULAR FEMORAL HEAD WITH OFFSET TRUNION

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

KIRSCHNER MEDICAL CORP.

The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Modular Femoral Head With Offset Trunion.

Pre-market Notification Details

Device IDK914675
510k NumberK914675
Device Name:MODULAR FEMORAL HEAD WITH OFFSET TRUNION
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
ContactSam Son
CorrespondentSam Son
KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-18
Decision Date1992-08-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304256224 K914675 000
00880304256217 K914675 000
00880304256200 K914675 000
00880304256194 K914675 000
00880304256187 K914675 000
00880304255418 K914675 000
00880304255395 K914675 000
00880304255388 K914675 000
00880304007550 K914675 000

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