AUSTIN-MOORE MODULAR HIP PROSTHESIS

Prosthesis, Hip, Hemi-, Femoral, Metal

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Austin-moore Modular Hip Prosthesis.

Pre-market Notification Details

Device IDK845025
510k NumberK845025
Device Name:AUSTIN-MOORE MODULAR HIP PROSTHESIS
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactLonnie Witham
CorrespondentLonnie Witham
BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-27
Decision Date1985-04-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304228290 K845025 000
00880304000735 K845025 000
00880304068100 K845025 000
00880304227972 K845025 000
00880304228054 K845025 000
00880304228184 K845025 000
00880304228214 K845025 000
00880304228221 K845025 000
00880304228245 K845025 000
00880304228269 K845025 000
00880304000148 K845025 000

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