REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Repicci Ii Unicondylar Knee All Poly Tibial Components.

Pre-market Notification Details

Device IDK980665
510k NumberK980665
Device Name:REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-20
Decision Date1998-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304184923 K980665 000
00880304008144 K980665 000
00880304008137 K980665 000
00880304008083 K980665 000
00880304002401 K980665 000

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