ZIRCONIA CERAMIC MODULAR HEADS

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 Zirconia Ceramic Modular Heads.

Pre-market Notification Details

Device IDK905687
510k NumberK905687
Device Name:ZIRCONIA CERAMIC MODULAR HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia M Sandborn
CorrespondentPatricia M Sandborn
BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-19
Decision Date1991-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304255326 K905687 000
00880304255265 K905687 000
00880304001480 K905687 000

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