BIPOLAR FEMORAL HEAD

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

WHITESIDE BIOMECHANICS, INC.

The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Bipolar Femoral Head.

Pre-market Notification Details

Device IDK981238
510k NumberK981238
Device Name:BIPOLAR FEMORAL HEAD
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis,  MO  63141
ContactMichael C Wall
CorrespondentMichael C Wall
WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis,  MO  63141
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-03
Decision Date1998-08-21
Summary:summary

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