BIOLOX DELTA CERAMIC OPTION 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 Biolox Delta Ceramic Option Heads.

Pre-market Notification Details

Device IDK141653
510k NumberK141653
Device Name:BIOLOX DELTA CERAMIC OPTION HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
Product CodeLZO  
Subsequent Product CodeJDI
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeMAY
Subsequent Product CodeOQG
Subsequent Product CodeOQH
Subsequent Product CodeOQI
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-20
Decision Date2014-08-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.