HAMMERLOCK 2

Pin, Fixation, Smooth

BIOMEDICAL ENTERPRISES, INC

The following data is part of a premarket notification filed by Biomedical Enterprises, Inc with the FDA for Hammerlock 2.

Pre-market Notification Details

Device IDK133520
510k NumberK133520
Device Name:HAMMERLOCK 2
ClassificationPin, Fixation, Smooth
Applicant BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio,  TX  78245
ContactJoe Soward
CorrespondentJoe Soward
BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio,  TX  78245
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-15
Decision Date2014-01-09
Summary:summary

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