M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for M2a Magnum 12/14 Taper Inserts And One-piece Modular Heads.

Pre-market Notification Details

Device IDK061423
510k NumberK061423
Device Name:M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-23
Decision Date2006-07-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304537392 K061423 000
00880304647336 K061423 000
00880304647312 K061423 000
00880304647299 K061423 000
00880304647275 K061423 000
00880304647268 K061423 000
00880304476936 K061423 000
00887868462993 K061423 000

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