BIOPRO FEMORAL HIP COMPONENT

Prosthesis, Hip, Hemi-, Femoral, Metal

BIOPRO, INC.

The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Femoral Hip Component.

Pre-market Notification Details

Device IDK872535
510k NumberK872535
Device Name:BIOPRO FEMORAL HIP COMPONENT
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant BIOPRO, INC. 17 17TH ST. Port Huron,  MI  48060
ContactSerafin, Jr.
CorrespondentSerafin, Jr.
BIOPRO, INC. 17 17TH ST. Port Huron,  MI  48060
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-26
Decision Date1987-08-26

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