LACTOSCREW SCREW ANCHOR

Screw, Fixation, Bone

BIOMET ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Lactoscrew Screw Anchor.

Pre-market Notification Details

Device IDK033355
510k NumberK033355
Device Name:LACTOSCREW SCREW ANCHOR
ClassificationScrew, Fixation, Bone
Applicant BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactMary L Verstynen
CorrespondentMary L Verstynen
BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-20
Decision Date2004-06-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304453401 K033355 000
00880304453395 K033355 000

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