THE NEW BIO-MOORE ENDO HEADS

Prosthesis, Hip, Hemi-, Femoral, Metal

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for The New Bio-moore Endo Heads.

Pre-market Notification Details

Device IDK984028
510k NumberK984028
Device Name:THE NEW BIO-MOORE ENDO HEADS
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactTracey J Bickel
CorrespondentTracey J Bickel
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-12
Decision Date1999-01-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304221918 K984028 000
00880304221758 K984028 000
00880304221734 K984028 000
00880304221727 K984028 000
00880304221710 K984028 000
00880304221703 K984028 000
00880304221697 K984028 000
00880304007499 K984028 000
00880304001565 K984028 000
00880304221772 K984028 000
00880304221802 K984028 000
00880304221819 K984028 000
00880304221901 K984028 000
00880304221895 K984028 000
00880304221888 K984028 000
00880304221871 K984028 000
00880304221857 K984028 000
00880304221840 K984028 000
00880304221833 K984028 000
00880304221826 K984028 000
00880304221789 K984028 000

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