REGENEREX TIBIAL COMPONENTS

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Regenerex Tibial Components.

Pre-market Notification Details

Device IDK080361
510k NumberK080361
Device Name:REGENEREX TIBIAL COMPONENTS
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
ContactSusan Alexander
CorrespondentSusan Alexander
BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-11
Decision Date2008-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304497092 K080361 000
00880304463585 K080361 000
00880304463592 K080361 000
00880304463608 K080361 000
00880304463615 K080361 000
00880304463622 K080361 000
00880304463639 K080361 000
00880304463646 K080361 000
00880304478145 K080361 000
00880304479920 K080361 000
00880304495227 K080361 000
00887868252204 K080361 000

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