LACTOSORB MINI INTERFERENCE SCREW

Screw, Fixation, Bone

BIOMET ORTHOPEDICS, INC.

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

Pre-market Notification Details

Device IDK021254
510k NumberK021254
Device Name:LACTOSORB MINI INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant BIOMET ORTHOPEDICS, INC. 56 EAS BELL DR. P.O. BOX 587 Warsaw,  IN  46582
ContactSara B Shultz
CorrespondentSara B Shultz
BIOMET ORTHOPEDICS, INC. 56 EAS BELL DR. P.O. BOX 587 Warsaw,  IN  46582
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-19
Decision Date2002-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304423688 K021254 000

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