LACTOSORB RAPIDFLAP

Plate, Bone

BIOMET, INC.

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

Pre-market Notification Details

Device IDK003281
510k NumberK003281
Device Name:LACTOSORB RAPIDFLAP
ClassificationPlate, Bone
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactCarol Lauster
CorrespondentCarol Lauster
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-19
Decision Date2001-08-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036053864 K003281 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.