REACH FEMORAL COMPONENT

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Reach Femoral Component.

Pre-market Notification Details

Device IDK000760
510k NumberK000760
Device Name:REACH FEMORAL COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactMichelle L Mckinley
CorrespondentMichelle L Mckinley
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-08
Decision Date2000-05-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304200722 K000760 000
00880304011120 K000760 000

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