LACTOSORB PLATES, MESHES, AND PANELS/SHEETS

Plate, Fixation, Bone

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Plates, Meshes, And Panels/sheets.

Pre-market Notification Details

Device IDK011237
510k NumberK011237
Device Name:LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
ClassificationPlate, Fixation, Bone
Applicant BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactDalene T Binkley
CorrespondentDalene T Binkley
BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-23
Decision Date2001-05-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304563834 K011237 000
00880304452480 K011237 000
00880304449954 K011237 000
00880304445130 K011237 000
00880304419933 K011237 000
00880304419902 K011237 000
00880304002692 K011237 000

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