DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE

Plate, Fixation, Bone

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Dvr Dorsal Plate, Dvr Lateral Plate, Dvr Ulna Plate.

Pre-market Notification Details

Device IDK140622
510k NumberK140622
Device Name:DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
ClassificationPlate, Fixation, Bone
Applicant BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
ContactSuzana Otano
CorrespondentSuzana Otano
BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-11
Decision Date2014-05-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868132933 K140622 000
00887868077104 K140622 000
00887868077111 K140622 000
00887868077142 K140622 000
00887868077159 K140622 000
00887868077166 K140622 000
00887868129377 K140622 000
00887868129384 K140622 000
00887868129391 K140622 000
00887868129407 K140622 000
00887868129414 K140622 000
00887868129421 K140622 000
00887868129438 K140622 000
00887868129445 K140622 000
00887868129452 K140622 000
00887868129469 K140622 000
00887868132926 K140622 000
00887868446078 K140622 000

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