MICROPLASTY TIBIAL TRAYS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Microplasty Tibial Trays.

Pre-market Notification Details

Device IDK063732
510k NumberK063732
Device Name:MICROPLASTY TIBIAL TRAYS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-18
Decision Date2007-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304554498 K063732 000
00880304554481 K063732 000
00880304554474 K063732 000
00880304554467 K063732 000
00880304554450 K063732 000
00880304554443 K063732 000
00880304554436 K063732 000
00880304009738 K063732 000

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