INTERLOK BIO-MODULAR HUMERAL STEMS

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Interlok Bio-modular Humeral Stems.

Pre-market Notification Details

Device IDK032507
510k NumberK032507
Device Name:INTERLOK BIO-MODULAR HUMERAL STEMS
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWT  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-14
Decision Date2003-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304213814 K032507 000
00880304213685 K032507 000
00880304213708 K032507 000
00880304213715 K032507 000
00880304213739 K032507 000
00880304213746 K032507 000
00880304213760 K032507 000
00880304213784 K032507 000
00880304213791 K032507 000
00880304213807 K032507 000
00880304204447 K032507 000

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