ABC TOTAL ELBOW PROTHESIS

Prosthesis, Elbow, Semi-constrained, Cemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Abc Total Elbow Prothesis.

Pre-market Notification Details

Device IDK972691
510k NumberK972691
Device Name:ABC TOTAL ELBOW PROTHESIS
ClassificationProsthesis, Elbow, Semi-constrained, Cemented
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactKarl Schwartz
CorrespondentKarl Schwartz
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeJDB  
CFR Regulation Number888.3160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-17
Decision Date1997-10-15
Summary:summary

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