BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE

Pin, Fixation, Smooth

BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Bioscience, Inc. with the FDA for Biofix Absorbable Self-reinforced Poly-l-lactide.

Pre-market Notification Details

Device IDK925098
510k NumberK925098
Device Name:BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE
ClassificationPin, Fixation, Smooth
Applicant BIOSCIENCE, INC. 555 THIRTEENTH ST. NW Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
BIOSCIENCE, INC. 555 THIRTEENTH ST. NW Washington,  DC  20004 -1109
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-08
Decision Date1994-07-19

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