SMOOTH OR THREADED METALLIC BONE FASTENER

Pin, Fixation, Smooth

BIOMEDICAL ENT., INC.

The following data is part of a premarket notification filed by Biomedical Ent., Inc. with the FDA for Smooth Or Threaded Metallic Bone Fastener.

Pre-market Notification Details

Device IDK131640
510k NumberK131640
Device Name:SMOOTH OR THREADED METALLIC BONE FASTENER
ClassificationPin, Fixation, Smooth
Applicant BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio,  TX  78245
ContactJoe Soward
CorrespondentJoe Soward
BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio,  TX  78245
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-04
Decision Date2013-10-16
Summary:summary

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