HOWMEDICA ALUMINA FEMORAL HEAD

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

PFIZER HOSPITAL PRODUCTS GROUP, INC.

The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Howmedica Alumina Femoral Head.

Pre-market Notification Details

Device IDK915184
510k NumberK915184
Device Name:HOWMEDICA ALUMINA FEMORAL HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactDenise E Murphy
CorrespondentDenise E Murphy
PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-18
Decision Date1992-01-31

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