2MM PEDIATRIC FLEX NAIL

Pin, Fixation, Smooth

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 2mm Pediatric Flex Nail.

Pre-market Notification Details

Device IDK022531
510k NumberK022531
Device Name:2MM PEDIATRIC FLEX NAIL
ClassificationPin, Fixation, Smooth
Applicant BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw,  IN  46581 -0587
ContactTracy J Bickel
CorrespondentTracy J Bickel
BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-31
Decision Date2002-08-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304487277 K022531 000
00880304285712 K022531 000

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