MODULAR ARTHRODESIS NAIL

Rod, Fixation, Intramedullary And Accessories

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Modular Arthrodesis Nail.

Pre-market Notification Details

Device IDK042409
510k NumberK042409
Device Name:MODULAR ARTHRODESIS NAIL
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-03
Decision Date2004-12-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304083073 K042409 000
00880304082984 K042409 000
00880304082991 K042409 000
00880304083004 K042409 000
00880304083011 K042409 000
00880304083028 K042409 000
00880304083035 K042409 000
00880304083042 K042409 000
00880304083059 K042409 000
00880304083066 K042409 000
00880304082977 K042409 000

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