ARCOMXL ACTIVE ARTICULATION

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Arcomxl Active Articulation.

Pre-market Notification Details

Device IDK110555
510k NumberK110555
Device Name:ARCOMXL ACTIVE ARTICULATION
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactBekcy Earl
CorrespondentBekcy Earl
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeLPH  
Subsequent Product CodeKWY
Subsequent Product CodeLZO
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-28
Decision Date2011-03-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00880304527393 K110555 000
00880304491328 K110555 000
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00880304491397 K110555 000
00880304491403 K110555 000
00880304491410 K110555 000
00880304491427 K110555 000
00880304527409 K110555 000

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