MALLORY-HEAD TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mallory-head Total Hip System.

Pre-market Notification Details

Device IDK921181
510k NumberK921181
Device Name:MALLORY-HEAD TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-10
Decision Date1994-02-16

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