IMPACT MODULAR TOTAL HIP SYSTEM

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 Impact Modular Total Hip System.

Pre-market Notification Details

Device IDK000334
510k NumberK000334
Device Name:IMPACT MODULAR TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactFred Mcclure
CorrespondentFred Mcclure
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-03
Decision Date2000-02-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304211087 K000334 000

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