BIOMET BIPOLAR PROSTHESIS

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Bipolar Prosthesis.

Pre-market Notification Details

Device IDK833175
510k NumberK833175
Device Name:BIOMET BIPOLAR PROSTHESIS
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant BIOMET, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-19
Decision Date1983-12-22

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