ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

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

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Arcomxl Polyethylene Liners And 38/40mm Femoral Heads.

Pre-market Notification Details

Device IDK062997
510k NumberK062997
Device Name:ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-02
Decision Date2006-12-08
Summary:summary

NIH GUDID Devices

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